Evidence Based Contraceptive Management

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					Evidence Based                                                              What’s New and Controversial?
                                                                        New Contraceptive Methods
Contraceptive                                                             – ENG Contraceptive Implant (Implanon)
                                                                          – Hysteroscopic tubal occlusion (Essure)
Management                                                              Intrauterine contraceptive (IUC)
                                                                          – Client selection
           Michael S. Policar, MD, MPH                                    – Pre-insertion screening criteria
       Dept of Ob, Gyn, and Reproductive Sciences
                                                                        DMPA
                                                                          – Extension of grace period
                UCSF School of Medicine
                                                                          – DMPA and fracture risk
             www.PolicarLectures.com




       What’s New and Controversial?                                    WHO Medical Eligibility Criteria for
                                                                         Contraceptive Use – 3rd edition - 2004
 Combined Hormonal Methods                                              – www.who.int/reproductive-
   – Nuvaring cycling                                                      health/publications/mec/
   – OrthoEVRA and venous events                                         – www.reproductiveaccess.org/
   – Quick start                                                           contraception/WHO_chart.htm
   – New OC products                                                    WHO Selective Recommendations for
                                                                         Contraceptive Use 2008
                                                                         – http://www.who.int/reproductive-
                                                                           health/publications/spr/index.htm




   WHO Medical Eligibility Criteria                                              ENG Implant: Implanon
Category             Definition                Recommendation            Progestin only, single rod, subdermal implant
   1       No restriction in contraceptive   Use the method              effective for up to 3 years
           use
                                                                         Studied in 17 countries, including US
   2       Advantages generally outweigh More than usual
                                                                          – Marketed in 30 countries; > 2.5 million insertions
           theoretical or proven risks   follow-up needed
   3       Theoretical or proven risks       Clinical judgment that
                                                                         Supplied in a sterile and disposable preloaded
           outweigh advantages of the        this patient can safely     applicator
           method                            use                         Inserted subdermally between biceps and triceps
   4       The condition represents an       Do not use the method       Must be inserted and removed only by clinicians
           unacceptable health risk if the                               that have completed training program
           method is used
                                                                                                                                                           Contraceptive Efficacy of
         ENG Implant: Mechanism of Action
                                                                                                                                                                ENG Implant
    Inhibits ovulation                                                                                                  Initial study (Glasier A, Contraception 2002)
     – No ovulation was observed for 30 months in                                                                         – No pregancies reported in 73,429 cycles
       clinical trials                                                                                                    – Pearl Index: 0-0.10 failures per 100 couples/ year
        »Only 2 out of 31 (6.5%) subjects ovulated                                                                       US studies (Implanon package insert)
          in year 3, with no resulting pregnancies                                                                        – 6 pregancies reported in 20,648 cycles
    Secondarily increases viscosity of cervical                                                                          – Each conception immediately after removal
     mucus
                                                                                                                          – Pearl index: 0.38 failures per 100 couples/ year
                                                                                                Organon Data on File;
                                                                                           Implanon™ [package insert]   .




                Patient Weight and ENG Levels                                                                                            ENG Implant: Return to Fertility
                      (Ovulation Risk)
                                                                                                                                                             n = 14
                                                                                                                                                     400
                                                                                                                             Etonogestrel (pg/mL)


         250                                                                                                                                                                                         • ENG Levels
                                 Levels extrapolated to 3 years of use
                                                                                                                                                     300                                             undetectable
         200
                                                                                                                                                                                                     within 1 week
 g m




         150                                                                                                                                         200
p /




                                                                                                            Inhibits
         100                                                                                                ovulation
                                                                                                                                                     100

          50

            0                                                                                                                                                         1          10          5
                     <50           50–60          60–70          70–80           80–90            >90
                                                                                                                                                                          Hours             Days     Davies. Contraception 1993
                                                            kg
                                                                                                                                                                             Post-Removal           Croxatto. Contraception 1998
       Croxatto HB, Makarainen L. Contraception. 1998;58(suppl 6):91S–97S; Huber J, et al. Contraception.                                                                                          Lahteenmaki. Fertil Steril 1980
       1998;58(suppl 6):85S–90S; Organon data on file.




                        ENG Implant: Candidates                                                                                                                            ENG Implant
                                                                                                                                                    2004 WHO Medical Eligibility Criteria
  Women who want continuous pregnancy protection
   – With long duration of action (2-3 years)
                                                                                                                             WHO- Category 4
   – Without daily or weekly patient intervention
  Accepting of variable vaginal bleeding patterns                                                                                           – Current breast cancer
  Desire a low dose estrogen-free contraceptive                                                                             WHO- Category 3
  Precautions (package insert)                                                                                                              – Past breast cancer (> 5 years ago, no recurrence)
   – Known or suspected pregnancy                                                                                                            – Current deep vein thrombosis
   – Current or past history of thrombotic disease                                                                                           – Active liver disease or history of liver tumors
   – Hepatic tumor, active liver disease                                                                                                     – Less than 3 weeks post-partum
   – Known or suspected breast cancer
   – Hypersensitivity to any component of Implanon
                             ENG Implant: Vaginal Bleeding                                                                  ENG Implant: Vaginal Bleeding
               Bleeding pattern is unpredictable (all unscheduled)
               No trends with time                                                                                 Counseling points
               Smaller amount of bleeding than cycling women                                                        – You will have fewer bleeding episodes
               Continuous progestin prevents EM hyperplasia;                                                        – You will have the same or fewer bleeding days
                        endometrial biopsy unnecessary for this purpose                                             But,
               Management                                                                                           – Your bleeding days, episodes will be
                             »Counseling and reassurance                                                               unpredictable
                             »Ibuprofen 400-600 mg TID for 7-days, or                                                – You may have more spotting days than before
                             »Estradiol 1-2 mg PO QD for 10-14 days, or
                             »OCs, given for 2-3 cycles




                        ENG Implant: Discontinuation Rates                                                               ENG Implant: Bone Mineral Density
                                          Number at study initiation = 1,300
                        14                                                                                          Head-to-head study of ENG rod with non-
                        12                                                                                             medicated IUD (copper)
(% of Total Subjects)




                        10                                                                                          No differences in BMD changes between
Discontinuation




                                                                                                   Year 1
                         8
                                                                                                   Year 2            2 groups
                         6                                                                         Year 3           No bone loss occurs during use
                         4
                                                                                                                    Comment: would not expect bone loss, since
                         2
                                                                                                                     estrogen levels are not reduced, as with DMPA
                         0
                              Frequent   Prolonged   Weight Gain   Emotional        Acne
                                                                                            Organon Data on File
                              Bleeding    Bleeding                  Lability
                                                                                      Croxatto. Hum Reprod 1999
                                                                                       Zheng. Contraception 1999    Beerthuizen R, et al. Hum Reprod. 2000;15:118–122.




                             ENG Implant: Weight Change                                                                      ENG Implant: Insertion Timing
               Small but steady weight increases seen                                                              Standard start-up
               In a comparative analysis, weight increase seen                                                       – Insertion within 5 days of initiation of menses
                 – 21% of women                                                                                     Switching from combined hormonal methods
                 – Drug-related in only 6.4%                                                                          – Insertion within 7 days of last active dose
               A comparative study found mean increase similar                                                     Switching from progestin-only method
                to that seen with non-medicated IUD                                                                   – Insertion any day with use of progestin only-pill
               Comment: advise the patient that Implanon use                                                         – Same day as IUC or implant removal
                may have a minimal impact on weight gain, but                                                         – On due date for next contraceptive injection
                that she may gain weight for other reasons
                                                                               Urbancsek J. Contraception 1998                                                           Implanon package labeling
      ENG Implant: Insertion Timing                                                    ENG Implant Insertion and
                                                                                        Removal Time (Minutes)*
 Quick start: insert anytime in cycle                                                                                     ENG Implant LNG Implant
  – Condoms for next 7 days                                                                             N                          670                665
  – Emergency contraception if unprotected sex <5 days                   Insertion                      Mean                       1.1min             4.3 minutes
  – Exclude pregnancy if >10 days from ovulation                                                        Min-max                    0.03–5.0           0.83–18.0
 First trimester abortion                                                Removal                       N                         633                 137
  – Within 5 days of procedure or miscarriage                                                           Mean                      2.6 min             10.2 minutes
 Childbirth or 2nd trimester abortion                                                                  Min-max                   0.2–20.0            1.3–50.0
  – 3-4 weeks after completion of pregnancy
 Exclusive breast-feeding
  – After 4th post-partum week
                                            Implanon package labeling    Mascarenhas L. Eur J Contracept Reprod Health Care. 2000;5(suppl 2):29–34.




     Insertion of Implanon (vs Norplant)                                   ENG Implant: Counseling Messages
 One flexible rod (vs 6 capsules…and 6 tracks)                          High efficacy relative to other methods
 One rod is pre-loaded in inserter (vs load each)                       Describe expected bleeding pattern
 Applicator designed to puncture skin (vs scalpel)                      No adverse effect on BMD, weight; MI or DVT risk
 Applicator designed to deposit rod under skin (vs
  retracting trochar hub while holding stylette)
                                                                         Rapid reversibility
 Consequently, insertion and removal is…                                No protection against STD or HIV
   – More comfortable (less pain) for the patient                        Insertion and removal procedures
   – More rapid time to completion                                       Costs and insurance coverage
   – Simpler for clinician to perform                                    Differences between Implanon and Norplant …if
   – Easier for clinician to learn I/R techniques                          she remembers Norplant!!




          Implanon: Benefit Issues                                                         Implanon: Benefit Issues
 Insurance Coverage                                                     Single distributor: CuraScript Specialty Pharmacy
  – Insertion/ removal almost always covered                              – Provider orders and pays for kit, then bills insurer, or
  – Implanon kit: may cover, exclude, or co-payment                       – Provider faxes referral form, insurer pays for kit, or
  – Medicaid coverage variable                                            – Patient can either pay provider or pay CuraScript
 Reimbursement issues                                                   Provider qualifications
  – Professional fee
                                                                          – After participation in a Implanon 3 hour training,
     »11975 (insertion), 11976 (removal), 11977 (I/R)                       clinicians are assigned a “training ID number”
  – Insertion kit (approximate)
                                                                          – Organon rep follows-up with provider in 30 days
     » Cost to patient              $ 600
     » Cost to physician            $ 500                                 – Orders submitted to Curascript are verified with
                                                                            clinician state license + Organon provider number
     » 340B program price           $ 250
   Essure Permanent Birth Control System                              Sterilization Comparisons
 Essure micro-insert is placed in proximal portion                            Hysteroscopic      Tubal      Vasectomy
  of each fallopian tube lumen                                                  Sterilization    Ligation

 Micro-insert expands upon release and anchors           Incisions                None            1-2          1-2
  itself in the tube                                      Typical                Local or        General       Local
 Subsequent benign local tissue in-growth over a 3-      anesthesia            IV Sedation
  month period…scarring blocks fallopian tube             Peritoneal entry          No             Yes          No
 Device permanently anchored in occluded fallopian       Resume activities       1-2 days       4.4 days     2 days
  tube, resulting in permanent contraception
                                                          Effectiveness rate      99.74%         98.82%       98.87%
                                                                                  @5 years       @ 4 years    @ 5 years




               Essure: Candidates                            Essure: Post-Placement Follow-Up
  Women who prefer this approach to laparoscopy           Low pressure hysterosalpingogram (HSG) is
                                                            recommended 3 months after Essure
  Especially, for women with …
                                                             – Radiologist training and access issues?
    – Obesity (BMI of > 45)
                                                             – Protocol can be downloaded from website
    – Abdominal mesh that prevents laparoscopy
    – Permanent colostomy
                                                           Determine who is responsible for notifying patient;
                                                            surgeon or referring provider
    – Multiple abdominal/pelvic surgeries (adhesions)
                                                             – Notification letters available from website
    – Use of anticoagulation medications
    – Medical problems that contraindicate general
                                                           If occlusion is not demonstrated, repeat HSG three
                                                            months later
      anesthesia




             Essure: Benefit Issues                                     Essure: Summary
 Provider qualifications                                  Essure increases procedure safety profile
   – Must be an experienced hysteroscopist                  – No incisions required
   – Initial placement rates 86-90%, then improve           – No general or regional anesthesia
   – Training and proctoring required for certification     – Micro-insert contains no hormones
 Insurance Coverage                                       Use in patients not eligible for incisional surgery
   – Most commercial insurance health plans                 – Morbid obesity
   – Most Medicaid and state Family Planning programs       – Prior abdominal/pelvic surgery
 Costs                                                    Healthcare system savings
   – In OR, more expensive than laparoscopic tubal
                                                            – When performed in an office setting
   – In office, about equal to laparoscopic tubal
Intrauterine Contraception in the U.S.                                                         Why IUCs Are Underused in the US?
                                                                                              Lack of awareness of method among women
               ParaGard                             Mirena                                    Dearth of trained, willing clinicians to insert
Mechanism      Copper ions                          Levonorgestrel                              – Misconceptions regarding difficulty of insertion
Duration       10 years                             5 years                                     – Negative publicity, fear of litigation
Efficacy (typ) 0.8 failures/hwy                     0.1 failures/hwy                            – Upfront cost
Benefit        No hormones                          Less bleeding                             2007 Contraceptive Technology Update Survey
Non contra     None                                 Menorrhagia                                 – 40% of respondents inserted > 6 IUDs in the last
-ceptive uses                                       Endometriosis                                 year…compared to 45% in 2006
Cost           Less expensive                       More expensive                              – 40% reported no insertions
                                                                                                                                                     Weir E. CMAJ. 2003.
                                                                                                                                                     Stanwood NL, et al. Obstet Gynecol. 2002.
                                                                                                                                                     Steinauer JE, et al. Fam Plann Perspect. 1997.




 Most Young Pregnant Women Unsure                                                                                  What Do Women Find
      About IUD Characteristics                                                                                   Unacceptable About IUDs?
Of women who had heard of IUDs (50%)
                                                                                               Lack of objective information
                 71%                                                                           Reported side effects
                                                          58%                                  Anxiety about IUD insertion
                                                                                               Infection risk
                                                                                               Lack of personal control of IUD after
                                                                                                   insertion
           Unsure of safety                       Unsure of efficacy
                                                                                             Asker C, et al. J Fam Plann Reprod Health Care. 2006.
                    Stanwood NL, et al. Obstet Gynecol. 2006.




 Rate of PID by Duration of IUC Use                                                                                    IUCs Do Not Cause PID
                                      n=20,000 women.
                                                                                               PID incidence for IUC users is similar to that of the
           10
                                                                                                general population
            8
                                                                                               Risk is increased only during the first month after
            6                                                                                   insertion
Rate per
 1000       4                            Baseline PID risk:                                    Preexisting STI at time of insertion, not the IUC
Woman-                                   1-2 cases /TWY                                         itself, increases risk
 Years      2

            0
                                                                                               No reason to restrict use based on sexual behaviors
                        20 days                       21 days - 8 years
                                   Duration of Use
                                                                                             Svensson L, et al. JAMA. 1984.
                                                                                             Sivin I, et al. Contraception. 1991.
                                   Adapted from Farley T, et al. Lancet. 1992;339:785-788.   Farley T, et al. Lancet. 1992.
         Fertility Rates in Parous Women After
                                                                                              IUC: Use in Nulliparous Women
           Discontinuation of Contraceptive
                  100                                                                 Use of IUCs by nulliparous women with low risk
                  80
                                                                                       of PID is safe and effective1-4
                                                                                      LNG-IUS is appropriate for nulliparous women
    Pregnancies




                  60                                           IUC
                                                                                       with menorrhagia and/or dysmenorrhea
       (%)




                                                               OC
                  40                                           Diaphragm              IUC expulsion, bleeding, and pain are slightly
                                                               Other methods           more likely among nulliparous women2-5
                  20

                   0                                                                1.   Suhonen S. Contraception 2004;69:507-512.
                        0           12         18       24      30      36     42   2.   Nelson AL. Obstet Gynecol Clin North Am. 2000;27:723-740.
                                                                                    3.   Dardano KL, Burkman RT. Am J Obstet Gynecol. 1999;181:1-5.
                                           Months After Discontinuation             4.   Li C. Contraception 2004;69:247-250.
Vessey MP, et al. Br Med J. 1983.
Andersson K, et al. Contraception. 1992.                                            5.   Treiman K, et al. Population Reports. 1995.
Belhadj H, et al. Contraception. 1986.




                   Pre-IUC Insertion Screening                                                          Pre-Insertion Guidelines
                                                                                          Prophylactic antibiotics
  Evidence supports no routine screening tests                                             – No value based on randomized clinical trials
    – Ct, GC: if high risk sexual behaviors or <26 yo                                     Premedication
      and annual screening Ct has not been done                                             – NSAID 1 hour before; cervical block if stenotic
    – Pregnancy test: only if pregnancy suspected                                         Timing of insertion
    – Pap smear: only if due for a routine Pap                                              – Copper: anytime, “as long as not pregnant”
    – Hematocrit: only if anemia suspected                                                  – LNG: insertion recommended by day 7
  Any indicated screening test can be done on the                                          – Back-up method if “off-cycle” insertion
   day of IUC insertion                                                                   May insert after delivery or abortion, but slightly
                                                                                           higher expulsion rate




            Is A Follow Up Visit Necessary?                                                          Elective Sterilization Rates
  Practices vary widely in the US
                                                                                                             Are Falling
  Two studies by WHO in Africa with non-medicated                                    Documented in US and UK over the past 10 years
   IUDs conclude that a follow-up visit is unnecessary                                Explanations
  Arguments for routine follow-up visit                                                   – Later childbearing; fewer years of protection needed
       – Early asymptomatic expulsion may be detected                                      – Wider use of long acting contraceptives, especially
       – Opportunity for further counseling                                                  IUCs and DMPA
       – Medico-legal “standard of practice”?                                                 » Advice from providers to use long acting
  Arguments against routine follow-up visit                                                    contraceptives instead of sterilization
       – All adverse effects other than expulsion have symptoms                            – Low payment rates by Medicaid and state Family
       – Can ask patient to come in if string cannot be felt                                 Planning Programs for ambulatory surgery
               Will Abdominal Sterilization
                    Become Obsolete?
 Traditional belief                  Now we know…
 Hormones dangerous >35 yo           Can be used till menopause
 IUCs dangerous at any age           IUCs are safe till menopause
 ITS is the most effective           IUCs, Implanon, and DMPA have
 contraceptive method                efficacy equal to ITS
 Laparoscopy is safer than           IUC, hysteroscopy are safer than
 laparotomy                          laparoscopy and laparotomy
 Regret is a rare event              40% with ITS at 18-24 yo later
                                     request information about reversal
 ITS is the most cost-effective      IUC is most cost effective method
 method over time                    over 5 years

 ITS: interval tubal sterilization        Grimes DA, Contraception 2008
                                          Williams JK, The Female Patient, 2007




                 DMPA and Osteoporosis                                                       DMPA and Osteoporosis
What we know                                                                       Biological plausibility
 In most studies, women who used DMPA had 5-10%
   lower bone mineral density than non-hormone users
                                                                                     – E2 in DMPA users averages “early follicle phase”
 Effect is seen in adolescents as well as older women                               – 24% users are very hypoestrogenic (<20 pg/ml)
 No relationship of duration of use and BMD loss                                  Most studies show post-discontinuation recovery of
 In populations of women tested, bone loss is reversible                           bone mass; however, questions remain...
   when DMPA stopped                                                                 – Is recovery of bone mass partial or complete?
But…                                                                                 – How long does it take to fully recover bone mass?
 The are no studies of fracture risk in DMPA users                                  – Will everyone recover bone mass, or just some?
 BMD is not an established surrogate marker for fracture                            – Is extent and rate of recovery related to duration?
   risk in younger women




    WHO 2004: DMPA, Age, and BMD                                                     What Is the Issue? Fracture Risk!!
 Menarche-18 years old                                                           Women under 40 years old
   – WHO-2: limited evidence shows decreased BMD                                    – Low impact fractures due to osteoporosis very rare
     over time; no studies evaluate impact on peak BMD                              – No data that DMPA use increases fracture risk before
 18-45 years old                                                                     menopause, but it is extremely unlikely
   – WHO-1: current DMPA users had decreased BMD,                                   – No data that DMPA increases post-menopausal fractures
                                                                                      in prior users who stopped < 40 years old
     usually within 1 SD of normal values
                                                                                    – Impact on an individual’s “peak BMD” is unknown
 Older then 45 years old
   – WHO-2: in PM women, no difference in BMD                                     However
     between former DMPA users and never users                                      – If DMPA reduces BMD, many years left to regain it
                                                                                    – No reason to time limit or offer “drug vacation”
           DMPA and Osteoporosis                                       DMPA and Osteoporosis
 Women 40 and older                                           Clinical recommendations
  Group of greatest concern, as there may be insufficient     BMD screening is inappropriate in this age group
   time to recover BMD                                           – BMD is not a proven surrogate marker of
  BMD in PM prior-users of DMPA is slightly lower than            fractures in pre-menopausal women
   non-users, but “unlikely” to affect fracture risk
                                                                 – Z-scores not helpful; T-scores not applicable
  Noting OP risk factors, three management options
    – Discontinue DMPA within next 1-2 years
                                                                 – No management guidelines offered by the FDA
    – Low dose (CE: 0.3 mg) estrogen “add-back”                  – Significant risk of over-treatment
    – Annual check of E2 in the week before next dose          The 2 year use threshold is relative, not absolute
       » > 20 pg/ml: no changes necessary                      Add this information to informed consent process
       » < 20 pg/ml: estrogen add-back or discontinue          Stay tuned for more information!!




       NuvaRing Duration of Action                                 Extended Regimen Nuva Ring
 Designed to be used 21 days on/ 7 days off                  429 women randomized, 289 (67%) completed
  – Advise initiation on or before day 5 (+ back up 7
                                                              Compared 4 regimens (21 days/ring; 7 day HFI)
    days) for new start users                                   – 28 day, 49 day, 91 day, 364 day cycles
 Duration of action is at least 4 weeks, possibly longer     All schedules well tolerated, completion rate higher
                                                               for shorter cycles
 Once removed, earliest ovulation is in 13 days
 Alternative use regimens                                    With longer regimens
                                                                – Scheduled bleeding days less
  – “Package insert”: 21 on/ 7 days off
                                                                – Spotting days increased (least with 28 day cycle)
  – 4 weeks on, then 4-7 day hormone free interval
  – “Calendar month”: use 1-25th, then off till the 1st
                                                              Adverse events, BP, weight, lab findings comparable
                                                                        Miller, Obstet Gynecol 2005;106:473




     OrthoEvra: Labeling Change 11/05                                OrthoEvra and Nonfatal VTE
                                                                        Jick SS, Contraception 2006,73:223
 Basis for labeling change: studies showing                    Retrospective study: Boston Collaborative Drug
   – Average ethinyl estradiol (EE) concentration 60%            Surveillance Program
     higher than 35 mcg OC
                                                                Case control study: cases = nonfatal VTE
   – Peak concentration of EE is 25% lower than 35
                                                               Method      Cases     Controls     Odds ratio
     mcg OC
                                                               NGM OC 37 (54%) 139 (52%) 1.0
   – Cumulative increase in EE levels over 3 weeks
                                                               Evra        31 (46%) 127 (48%) 0.9 (0.5-1.6)
   – “Not known” whether there are changes in the
     risk of serious adverse events                             Conclusion
 Persistent unsubstantiated “reports” of higher rates           – No increased risk of VTE in Evra users
  of venous (? arterial) events                                    compared to new users of NGM OCs
         OrthoEvra and Nonfatal VTE                               OrthoEVRA and Nonfatal VTE
            Jick SS, Contraception 2006,73:223

 216,000 women; 147K OCs, 59K patch                          i3 Drug Safety (Cole JA, OG 2007;109:339)
 Incidence of nonfatal VTE                                    – 2.2-fold increase in VTE in Evra vs. OC users
   – NGM OCs                4.2/10,000 women/year                 »NGM OCs              1.8/ 10,000 women/year
   – OrthoEvra              5.3/10,000 women/year                 »OrthoEvra            4.1/ 10,000 women/year
   – Age-adjusted RR        1.1 (95% CI: 0.7-1.8)              – Bias: new Evra users vs. new and prior OC users
 Historical comparisons                                          »VTE rate in OC users is lower than expected
   – Non pregnant           1 /10,000 women/year                   because prior OC users with DVT were excluded
   – OCs                    3-4/10,000 women/year
                                                               – Sample too small to evaluate MI, stroke
 Conclusion: risk of nonfatal VTE is similar in new users
  of OrthoEvra and new users of NGM OCs




     OrthoEVRA and Nonfatal VTE                                 Weight and Contraceptive Efficacy
 Clinical significance…until more is known
  – Higher level of caution regarding patch use in                     Top Tier:
    women with venous or arterial risk factors                         Female, male sterilization
  – Avoid extended patch regimens (>3 in a row)                        IUC, Implant,
                                                                                                                   Non-obese
     »E levels may be cumulative with each patch                       Middle Tier:                                2- 4/hwy
     »No safety data has been published to date                        DMPA,OC, Patch, Ring                        Obese
  – Use same precautions for patch that apply to OCs
                                                                       Bottom Tier:
 Comment: no reason for providers to discourage                       Everything Else
  OrthoEvra use in average risk women
                                                             Contraception in obese women is always safer than pregnancy




                                                                        Quick Start: Advice to Patients
   Standard OC Initiation vs. Quick Start
                                                                             Assume 28 day cycle
 Day 1 or Sunday start previously recommended, as
  – Later start might not inhibit ovulation                                                                                  Preg
                                                                                                                              test
  – Later start might expose embryo to hormones                                                  If unprotected sex d 7-14
  – Later start might cause irregular vaginal bleeding                                                   & no EC,
                                                                                                    pregnancy is possible
 Evidence says                                                                        Use EC if unprotected sex <120 hours
  – Condoms for 7 days will prevent pregnancy if early
    ovulation occurs                                                                       Use condoms for next 7 days
  – EC can be used within 120 hours of unprotected sex
                                                                      No back up
  – Exposure of embryo to OC is not teratogenic                         needed
                                                                  1                6             14               21                 28
                                                                                                OC start day
              Quick Start Compared to                                     Extended Cycle Contraception:
               Conventional OC Start                                          Consumer Acceptance
                                                                  National sample of 1,470 women
   1,716 women <25 yo; 3 public family planning clinics
   Randomly assigned to conventional start or quick start
                                                                   62% hadn’t used OCs for other than contracpn
   Follow up interviews at 3 and 6 months
                                                                   78% hadn’t used OCs to control menses
   Findings
                                                                   73% hadn’t heard of menstrual suppression
     – Quick start users more likely to use 2nd pack (OR=1.5) ,
                                                                   20% had received an OC Rx to skip periods
       but continuation rates same at 3, 6 months                  59% interested in not having a period every month
     – QS group 10% less likely to become pregnant                   – 1/3 would like to stop periods entirely
     – 81% rated QS as acceptable or preferable to waiting         57% of providers stated that their patients don’t ask
                                                                    about extended OC regimens
     – Serious adverse events low and same in both groups
              Westhoff C et.al. Obstet Gynecol 2007;109:1270-6                   Andrist, Contraception 2004; 70:359




                    New OC Products                                              New OC Products
 YAZ® (Bayer [Berlex]): 4/06                                      Loestrin 24® (Warner Chilcott): 2/06
   – EE 20 mcg + drosperinone 3 mg                                  – EE 20 mcg + nor acetate 1 mg + Fe fumarate
   – Cycle: 24 days active, 4 days hormone free                     – 24 days on, then 4 days Fe only
   Vs. Yasmin                                                       Vs. Loestrin 1/20: EE 20 mcg + nor acetate 1 mg
   – EE 30 mcg / drospirenone 3 mg                                  – 21 days on, 7 days off
   – Cycle: 21 days active, 7 days hormone free                    Lybrel® (Wyeth): 5/07
 Seasonique® (Duramed)                                             – EE 20 mcg + l-norgestrel 0.090 mg
   – EE 30 mcg + l-norgestrel (LNG) 0.150 mg                        – 28 active tablets; no hormone-free interval
   – 84 days of EE + LNG/ EE 10 mcg for 7 days                      Vs. Alesse
   Vs. Seasonale: same dose; 84 days on/ 7 days off                 – EE 20 mcg + l-norgestrel 0.10 mg
                                                                    – 21 days on, 7 days off




         Why The Trend Toward a 4-Day                                  Why The Trend Toward a 4-Day
         Hormone-Free Interval (HFI)?                                  Hormone-Free Interval (HFI)?
     Lower hormone doses more rapidly cleared than with            No head-to-head studies of 24/4 regimens compared
        older (and higher dose) OCs                                  to 21/7 regimens
       Higher FSH levels with 7 day HFI than with 4 day HFI        What we want to know…
       More follicle growth with 7 day HFI than with 4 day          – Is a 24/4 regimen really more effective than 21/7?
        HFI                                                          – Are bleeding patterns different between the two?
       So theoretically…                                            – Are there fewer menstrual symptoms with a 4 day
         – Lower failure rates with 24/4 cycles                        HFI compared to a 7 day HFI?
         – More forgiving of late initiation of new OC pack          – How much of the difference is marketing vs. real
                                                                       advantages?

				
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