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					                          Faculty of Sexual and Reproductive Healthcare
                          Clinical Effectiveness Unit

                          A unit funded by the FSRH and supported by Sandyford




                                      MEMBER’S ENQUIRY RESPONSE

Enquiry Reference: 2758                                                          Sent: 19.6.09
                                                                                 Prepared: 19.6.09

A: Question
In a young woman who has developed significant hirsutism and has normal blood tests, could this be
related to her use of the progestogen-only implant?

B: Response
There have been reports of hirsutism and hypertrichosis with use of the progestogen-only implant
Implanon. However there is no evidence of a causative relationship.

As there is no clear evidence of a causative effect the CEU has no information as to whether the
device should be removed. The CEU would suggest that if symptoms persist, the implant could be
removed and the symptoms monitored for signs of improvement. An alternative method of
contraception should be advised in the interim.




C: Evidence-Based Medicine Question (which guided our literature search strategy)
Population:      Young women

Intervention:    Implanon

Outcome:         Hirsutism

Keywords: Hirsutism, Hypertrichosis, Implanon, etonogestrel, implant, progestogen-only implant,
hair, 2758


D: Information Sources
The CEU searched the following sources in developing this Member’s Enquiry Response
                               Source Searched                                                Information Identified
Existing FSRH and RCOG guidance                                                           No relevant information
The National Guidelines Clearing House                                                    No relevant information
The United Kingdom Medical Eligibility Criteria for Contraceptive Use (2005/2006)         No relevant information
The United Kingdom Selected Practice Recommendations for Contraceptive Use (2002)
The World Health Organization Medical Eligibility Criteria for Contraceptive Use (2004)
The World Health Organization Selected Practice Recommendations for Contraceptive
Use (2005)
The Cochrane Library                                                                      No relevant information
MEDLINE and EMBASE from 1996 to 2008                                                      No relevant information




 Tel: 0141 232 8459                         Fax: 0141 232 8448                       email: ceu.members@ggc.scot.nhs.uk
E: Evidence Reviewed
Hirsutism is excess facial and body hair growth in the beard area, around the nipples and on the
abdomen, in an androgen dependent pattern. The condition is more common in dark haired individuals
and in particular racial groups, such as women of Mediterranean origin. The psychological impact on
the patient is often severe and many become depressed. The most common cause is idiopathic
resulting from hypersensitivity of the hair follicle to androgen. Other causes are: adrenal (congenital
adrenal     hyperplasia,    Cushing's   syndrome,        virilizing tumours);  pituitary (acromegaly,
hyperprolactinaemia); ovarian (polycystic ovarian syndrome, virilising tumours, gonadal dysgenesis);
                                                                                        1
iatrogenic (androgenic drugs, oral contraceptives, phenytoin); and Turner's syndrome.

Hypertrichosis is the growth of hair on any part of the body, in excess of the amount usually present in
persons of the same age, sex and race. Hypertrichosis lanuginosa may be applied to excessive
growth of fetal lanugo hair. The condition may be either congenital or acquired. It should not be
confused with hirsutism. Acquired hypertrichosis is most commonly iatrogenic. Offending agents
include streptomycin, especially in children, diazoxide, penicillamine, psoralens and minoxidil. The
condition usually resolves following withdrawal of the drug. Other causes can be from a manifestation
of systemic disease, for example: hepatoerythropoietic porphyria; endocrine dysfunction;
hyperthyroidism; anorexia nervosa; gross malnutrition; following mercury poisoning; or during the
second month of pregnancy. Hypertrichosis may also occur as a result of repeated irritation, friction or
chronic inflammation, for example: following occlusion of a limb by a plaster of Paris cast; after
prolonged application of mercurial ointment and iodine; occupational (for example, on the shoulders of
sack bearers); following excision of warts on the dorsum of the hands and fingers; or overlying chronic
                              1
osteomyelitis of the tibia.

There have been reports of hirsutism and hypertrichosis with use of the progestogen-only implant
Implanon. The summary of product characteristics for Implanon®2 notes hypertrichosis as an
uncommon (<1/100 ≥1/1000) possibly undersirable event reported during clinical trials. Hirsutism is
mentioned in the drug analysis print for etonogestrel. 4 cases have been reported, however this
number is the number of reports from the first of July 1963 till the 27th of April 20093. In a follow-up
study4 of 372 women 3 years after insertion of etonogestrel subdermal implants hirsutism was given
by 1 participant as a reason for discontinuation (0.3%). However there is no evidence of a causative
relationship.

As there is no clear evidence of a causative effect the CEU has no information as to whether the
device should be removed. The CEU would suggest that if symptoms persist, the implant could be
removed and the symptoms monitored for signs of improvement. An alternative method of
contraception should be advised in the interim.


F: References
      1. GP Notebook. Hirsutism.
         http://www.gpnotebook.co.uk/simplepage.cfm?ID=221577237&linkID=18787&cook=yes. 2009

      2. Organon Laboratories Limited. Implanon: Summary Product Characteristics (SPCs).
         http://www.medicines.org.uk. 2009

      3. Medicines and Healthcare Products Regulatory Agency. Drug Analysis Print- Etonogestrel.
         http://www.mhra.gov.uk/index.htm 2009

      4. Arribas-Mir L., Rueda-Lozano, D., Agrela-Cardona, M., Cedeno-Benavides, T., Olvera-Porcel,
         C., Bueno-Cavanillas, A. Insertion and 3-year follow-up experience of 372 etonogestrel
         subdermal contraceptive implants by family physicians in Granada Spain. Contraception 2009
         (Article in Press)


.


    Tel: 0141 232 8459               Fax: 0141 232 8448                email: ceu.members@ggc.scot.nhs.uk
The advice given in this Member's Enquiry Response has been prepared by the FSRH Clinical Effectiveness
Unit team. It is based on a structured search and review of published evidence available at the date of
preparation. The advice given here should be considered as guidance only. Adherence to it will not ensure a
successful outcome in every case and it may not include all acceptable methods of care aimed at the same
results. This response has been prepared as a service to FSRH members, but is not an official Faculty guidance
product; Faculty guidance is produced by a different and lengthier process. It is not intended to be construed or
to serve as a standard of medical care. Such standards are determined on the basis of all clinical data available
for an individual case and are subject to change as scientific knowledge advances. Members are welcome to
reproduce this response by photocopying or other means, in order to share the information with colleagues.

Enquiry response by JC
Checked by LM




 Tel: 0141 232 8459                     Fax: 0141 232 8448                    email: ceu.members@ggc.scot.nhs.uk

				
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