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					                                                    2/25/2011




   Hormonal Contraception


              John D. Davis, M.D.
  Associate Professor, Director of Gynecology
   Department of Obstetrics and Gynecology
    University of Florida College of Medicine




   Hormonal Contraception
FINANCIAL DISCLOSURE
I have no significant
financial interests or
other relationships with
industry relative to the
subject of this lecture.




   Hormonal Contraception
Learning Objectives
At the conclusion of this presentation,
attendees should be able to:
1. List th h        l    t      ti       il bl to
1 Li t the hormonal contraceptives available t
   women in the U.S.
2. Describe the advantages and disadvantages
   of these contraceptive methods.
3. State the contraindications to the use of
   combined hormonal contraceptives.




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     Hormonal Contraception

Outline
• Background

• Combined

• Intrauterine

• Progestin-only




     Hormonal Contraception
History
• Clinical research by John Rock in 1950s
• FDA approval of Enovid in 1960
  – 9.85 mg of norethynodrel
  – 150 mcg mestranol
• Availability
  – Married women in all states – 1965
  – Unmarried women in all states - 1972




     Hormonal Contraception
Progress

• Lower estrogen doses
  Less androgenic progestins
• L      d     i        ti

• Less pill-free days

• Alternative delivery methods




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     Hormonal Contraception
Pharmacology
• Progestins
  – Inhibit ovulation
  – Thicken cervical mucous
  – Thin the endometrium
• Estrogen (ethinyl estradiol-EE)
  – Contributes to ovulation
    inhibition
  – Stabilizes endometrium




     Hormonal Contraception
Importance
• ~ 50% of U.S. pregnancies
  unintended
• Patient education re options

• Counseling re correct use




                       *Finea LB et al. Perspect Sex Reprod Health 2006;38:91-6.




     Hormonal Contraception




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     Hormonal Contraception
 Combined Oral Contraceptives (COCs)

 • Over 25 available in U.S.
   20-35
 • 20 35 mcg EE/progestin
 • Monophasic and multiphasic
 • 21-day, 24-day, and extended
   cycle




     Hormonal Contraception
Contraceptive Vaginal Ring
• NuvaRing® (Merck)
• Approved by FDA in 2001
• Flexible ring, ~ 2 inches
• Releases 15 mcg EE/120 mcg
  etonogestrel per day
• Placed for 3 weeks




     Hormonal Contraception
Contraceptive Transdermal Patch
• Ortho Evra® (Ortho-McNeil-Janssen)
• Approved by FDA in 2002
• 20 cm2 patch
• Releases 20 mcg EE/150 mcg
  norelgestromin per day
• Worn weekly for 3 weeks




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             Progestins in U.S. COCs
Generation            Progestin           Progestin             Product(s)
                                            Type
First          Ethynodiol diacetate         Estrane      Demulen
               Norethindrone                             Ortho-Novum, Ovcon
               Norethindrone acetate                     Loestrin, EstroStep
Second         Norgestrel                  Gonane        Ovral, Lo/Ovral
               Levonorgestrel                            Alesse, Triphasil
                                                         Seasonale/ique
Third          Norgestimate                              Ortho-Cyclen, OTC
               Desogestrel                               Desogen, Mircette,
                                                         Cyclessa
Fourth         Drospirenone             Spir. analog     Yasmin, Yaz



                                         Modified from Edwards L. Formulary 2004;39:104-21.




    Combined Hormonal Contraception
     Failure and Continuation Rates*

                       1-Year Failure Rate (%)            1-Year Continuation
                                                               Rate (%)
Method             Typical Use         Perfect Use
COCs                        8              0.3                         68
NuvaRing®                   8              0.3                         68
Ortho Evra®                 8              0.3                         68

*See Appendix 1 for a summary of contraceptive efficacy




                                         www.contraceptivetechnology.org. Available online.




           Hormonal Contraception
Combined – Contraindications
• Estrogen effects on CV system
        – MI, stroke, VTE

• Eligibility criteria updated
  by CDC in 2010
• See Appendix 2




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         Hormonal Contraception
 Combined – Noncontraceptive Benefits
  Reduced:
 • Menstrual blood loss                    •   Hirsutism, acne
 • Iron deficiency anemia                  •   PID
 • Dysmenorrhea                            •   Rheumatoid arthritis
 • Endometrial/ovarian                     •   Colon cancer
   cancer
 • Benign breast disease                   • (↑BMD)




         Hormonal Contraception
Combined – Pill, Ring, or Patch?
• If satisfied, continue
• New start – patch concerns*:
     – Increased mean serum E levels vs. 35 mcg pill
     – Possibly 2-fold ↑ risk VTE
• New start – pill vs. ring:
     – Some women dislike ring


                       *ASRM Practice Committee. Fertil Steril 2008; 90:S103-13.




         Hormonal Contraception

  Combined – Pill Selection
 •   Third or fourth-generation
 •   No benefit to multiphasic1
 •   20 mcg pills no safer
 •   20 mcg pills may interfere with
     bone mass increase in
     adolescents2

              1. Van Vleit HA et al. Cochrane Database Syst Rev 2006; 3:CD002032.
              2. Polatti F et al. Contraception 1995;51:221-4.




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             Progestins in U.S. COCs
Generation            Progestin               Progestin              Product(s)
                                                Type
First          Ethynodiol diacetate             Estrane      Demulen
               Norethindrone                                 Ortho-Novum, Ovcon
               Norethindrone acetate                         Loestrin, EstroStep
Second         Norgestrel                       Gonane       Ovral, Lo/Ovral
               Levonorgestrel                                Alesse, Triphasil
                                                             Seasonale/ique
Third          Norgestimate                                  ORTHO-CYCLEN, OTC
               Desogestrel                                   DESOGEN, Mircette,
                                                             Cyclessa

Fourth         Drospirenone                 Spir. analog     YASMIN, Yaz




          Hormonal Contraception
Combined – New OC Formulations – 24 Day
• 24 active pills

  Yaz,
• Yaz Loestrin 24 Fe
        – Shorter periods
        – Greater suppression of
          follicular development1
• 20 mcg EE

                                       1. Schlaff WD et al. Am J Obstet Gynecol 2004;190:943-51.




          Hormonal Contraception
Combined – New OC Formulations - Extended
Name                 EE Dose (mcg)              LNG Dose                Regimen
                                                  (mcg)
Seasonale                       30                  150            84 Active,
                                                                            ,
                                                                    7 Placebo
Seasonique                      30                  150            84 Active
                                                                    7 10 mcg EE
Lybrel                          20                   90            Continuous


 • Second generation progestin
 • Spotting, unscheduled bleeding common
                                Blumenthal P, Edelman A. Obstet Gynecol 2008;112:670-84.




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         Hormonal Contraception
Combined - Ring
•   Lowest estrogen levels
•   Not known if lower VTE risk
•   Nausea still possible (5%)
•   Reasons for discontinuation*
    – Expulsion
    – Sensation
    – Sexual problems

                           *Dieben TO et al. Obstet Gynecol 2002;100:585-93.




         Hormonal Contraception
Combined - Patch
• Estrogen exposure 60% >35 mcg pills
• VTE risk: ~ 6/10k vs. ~ 3/10k
• Consider for poor pill takers
• Check daily for complete
  adherence
• Less effective if weight
  >198 lbs

                                  Ortho Evra prescribing information. Available online.




         Hormonal Contraception
     Combined – Side Effects
     Estrogen                     Progestin
     •   N/V                      •   Acne
     •   Fluid retention          •   Hirsutism
     •   Breast fullness          •   Weight gain
     •   Headache                 •   Mood swings
     •   Hypertension             •   Altered lipid profile


                  .




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     Hormonal Contraception
Combined – Management of Side Effects
• Estrogen-related
  – Decrease estrogen dose
  – Progestin only
• Progestin-related
  – Change progestin
  – Consider Mirena®




     Hormonal Contraception
Combined – Management of Missed Pills
• W.H.O. 2004 update
• Considerations:
  – Number of pills missed
  – When pills missed
  – EE content of pill
• See Appendix 3




     Hormonal Contraception




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          Hormonal Contraception
Levonorgestrol – Releasing IUD
• Mirena® IUS (Bayer)

• Approved by FDA in 2000

• T-shaped, 32 mm x 32 mm

• Releases 25 mcg LNG
  per day




          Hormonal Contraception
Mirena®
• 1-year failure rate of 0.2%

• Ectopic pregnancy rate of
  0.1% per year
• Effective for at least 5 years

• Prevents fertilization


                                                     Mirena ® prescribing information. Available online.




          Hormonal Contraception
Mirena® - Advantages
• User independent

• Highly effective

• Frequent resupply
  unnecessary
• Cost-effective

• Reversible, rapid fertility return
Increasing Use of Contraceptive Implants and Intrauterine Devices to Reduce Unintended Pregnancy.
ACOG Committee Opinion No. 450. Obstet Gynecol 2009;114:1434-8.




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         Hormonal Contraception
Mirena® - Noncontraceptive Benefits/Uses
• Reduced menstrual blood loss
    – ~20% amenorrheic at one year
    – Up to 50% at two years
• Off-label uses
    –   Menorrhagia
    –   Dysmenorrhea
    –   Endometriosis
    –   PMP endometrial
        protection
                       Blumenthal P, Edelman A. Obstet Gynecol 2008;112:670-84.




         Hormonal Contraception
Mirena® - Disadvantages
• Up-front cost
• Initial spotting, irregular
  bleeding
• Post-insertion infection
    – < 1%
    – Within 20 days
• Uterine perforation (< 1%)
• Expulsion (< 3%)

                       Blumenthal P, Edelman A. Obstet Gynecol 2008;112:670-84.




         Hormonal Contraception
Mirena® - Contraindications
•   Current pregnancy
•   Current pelvic infection
•   Unexplained vaginal bleeding
•   Malignancy
    – Cervix, endometrium, GTN
    – Breast
• Distorted uterine cavity
• Pelvic tuberculosis

                 CDC U.S. Medical Eligibility for Contraceptive Use , 2010. Available online.




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     Hormonal Contraception
IUD Utilization
• Worldwide, IUD is #1 reversible contraceptive

• Under utilized in U S
                    U.S.
  – Legacy of Dalkon Shield
• Except female Ob Gyns!
  – #1 choice if childbearing complete



                                    ACOG press release, December 9, 2003.




     Hormonal Contraception
IUD Utilization – Overcoming Barriers
• Patient education
• Nulliparity, adolescence not
  contraindications
• STD screening not mandatory
  – Recommended if new partner,
    <25 yo, recent STD
• Prophylactic antibiotics not required


                  Blumenthal P, Edelman A. Obstet Gynecol 2008;112:670-84.




     Hormonal Contraception




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     Hormonal Contraception
Depo Medroxyprogesterone Acetate
(DMPA)
• Depo Provera (Pfizer)
• Approved by FDA in 1992
• Two forms
   – 150 mg IM
   – 104 mg SC
     (depo-subQ Provera)
• 3-month dosing interval




     Hormonal Contraception
DMPA
• Perfect use 1-year failure rate
  = 0.3%
• Typical use 1-year failure rate
  = 0.3-3.0%
• Profound ovulation suppression



                            www.contraceptivetechnology.org. Available online.




     Hormonal Contraception
  DMPA
  Advantages            Noncontraceptive Benefits
  • Highly effective    • ↓ risk endometrial CA
  • Infrequent dosing   • ↓ dysmenorrhea, anemia,
  • No estrogen           PID, ovarian cysts,
    SC:                   ovulatory pain
  • Self-injection      • ↓ seizure incidence
  • Less painful        • ↓ sickle cell crises




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        Hormonal Contraception
DMPA
Side Effects                            Disadvantages
• AUB                                   • Delayed fertility
  – Variable                                  Avg.
                                            – Avg 10 months IM
  – Amenorrhea                              – Avg. 7 months SC
    50/80% at 1/3 y                     • BMD impact
• Weight gain
  – 5 lbs first year
  – 1-2 lbs/year thereafter
• Headache




        Hormonal Contraception
   DMPA - Contraindications
   Absolute
   • Current breast cancer




                   CDC U.S. Medical Eligibility for Contraceptive Use , 2010. Available online.




        Hormonal Contraception
 DMPA - Contraindications
 Relative
 • Multiple cardiac RF              •    SLE with + or ? aPLab
 • HTN – poorly                     •    RA/long-term steroids
                                         RA/long term
   controlled or with               •    Migraine with aura
   vascular disease                 •    Unexplained AUB
 • Ischemic heart                   •    Past breast cancer
   disease (current or
   past)                            •    DM - >20 years or 2° effects
 • Stroke                           •    Severe cirrhosis, liver
                                         adenoma, malignant tumor
                  CDC U.S. Medical Eligibility for Contraceptive Use , 2010. Available online.




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     Hormonal Contraception
 DMPA – Bone Density Impact
 • ~ 7% bone loss after 2 years
 • Reversible
 • No studies on osteoporosis
   or fracture risk in low-risk
   populations
 • 2004 FDA black box warning
    – D/C after 2 years unless
      alternatives inadequate

                                    ACOG Committee Opinion No 415 Obstet Gynecol.




     Hormonal Contraception
 DMPA – Bone Density/ACOG
 • Do not limit in adults
 • Benefits may outweigh
   risks in adolescents
 • Appropriate counseling
 • Calcium/vitamin D
 • No BMD testing
 • No ‘add-back’ estrogen
              1.   ACOG Practice Bulletin No. 73. American College of Obstetricians and
                   Gynecologists. Obstet Gynecol 2006;107:1453-72.
              2.   Blumenthal P, Edelman A. Obstet Gynecol 2008;112:670-84.




     Hormonal Contraception
Progestin-Only Pill
Progestin-
• “Mini-pill”
• Two available in U.S.
  – Micronor (Ortho-McNeil-Janssen)
  – Nor-QD (Watson)
• Norethindrone 0.35 mg
• Does not consistently
  inhibit ovulation




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      Hormonal Contraception
Progestin-
Progestin-Only Pill
• Once daily

  3-hour
• 3 hour window

• 1-year typical failure
   rate up to 13%




      Hormonal Contraception
Progestin-
Progestin-Only Pill – Candidates
• Breastfeeding
• Other hormonal methods contraindicated
  or poorly tolerated
• No current breast cancer
• Aware AUB may occur




      Hormonal Contraception
Implantable Progestin
• Implanon® (Organon)
• Approved by FDA in 2006
• Single 4 cm by 2 mm rod
   – 68 mg etonogestrel
• Subdermal; 3 years




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      Hormonal Contraception
Implanon®
• Similar mechanism of action as other
  progestin-containing contraceptives
• 1-year failure rate = 0.09%

• 1-year discontinuation
  rate = 16%:




      Hormonal Contraception
Implanon® Candidates
• No current breast cancer
• Estrogen contraindicated
• Poor IUD candidate
• Unable to return for q 3m
  injection
• Will tolerate AUB




      Hormonal Contraception

    Summary
    • Variety of hormonal
      contraceptives available
    • Advantages/disadvantages

    • Assist patient with choice




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        Hormonal Contraception
Selected References
1.   Blumenthal P, Edelman A. Hormonal Contraception.
     Obstet Gynecol 2008; 112:670-84.
2.   Use of Hormonal Contraception in Women With
     Coexisting Medical Conditions. ACOG Practice Bulletin
     No. 73. American College of Obstetricians and
     Gynecologists. Obstet Gynecol 2006;107:1453-72.
3.   CDC U.S. Medical Eligibility for Contraceptive Use ,
     2010. Available online.




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