Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?

• Status: Terminated
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance.

Methods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI.

A 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: Desogestrel; Etonogestrel

Criteria

Inclusion criteria:

• Women age of 18 - 42 years

• Interested in the use of ESI

• Accepting to have 90 days pre-treatment with OD

• Signed informed consent

Exclusion criteria:

• Pregnancy

• Lactation,

• vaginal bleeding of unknown origin,

• wish to become pregnant,

• weight over 80 kg,

• history of deep vein thrombosis/Pulmanory embolism,

• hypertension,

• Diabetes or other metabolic diseases,

• coagulation disorders,

• severe hepatic disorder,

• history of breast/endometrial cancer,

• known hypersensitivity to study drug,

• current treatment with enzyme inducing drugs (e.g.: phenytoin, carbamazepine, phenobarbital, etc.)