Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01963403
Brief Summary:
This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.
The hypothesis of the study is:
* Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant
* Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding
* Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant
Detailed Description:
Women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant will be recruited for this study. Women who have bothersome bleeding will be randomized to use either a combined oral contraceptive pill or a placebo pill.
Participants will take one pill every day and record their bleeding patterns on a daily diary.
Participants will have one screening/enrollment visit, two in-person follow up visits, and one telephone follow up contact. Subjects will be enrolled for a total of 84 days (three months).
Participants will be assigned to a treatment group at her screening/enrollment visit. Her first follow up visit will occur 22-28 days after her enrollment. Participants can choose to:
* Continue use of assigned treatment medication
* Discontinue use of assigned treatment medication, but use an open-label combined oral contraceptive pill
* Discontinue the use of assigned treatment medication, decline use of an open-label combined oral contraceptive pill
* Discontinue use of ETG implant.
Participants who choose to continue use of ETG implant will have a follow up telephone contact 50-56 days after her enrollment visit. A final in-person visit will occur 78-84 days after enrollment. Bleeding patterns will be assessed by daily bleeding diaries completed by the participant.
Study:
NCT01963403
Study Brief:
Protocol Section:
NCT01963403