Conditions: Abnormal Uterine Bleeding, Unspecified Uterine Bleeding Heavy
Keywords: etonogestrel implant birth control irregular bleeding heavy bleeding
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

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.

Arms:
arm 1: combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) arm 2: Placebo

Interventions: intervention 1: EE 30mcg/LNG 150mcg intervention 2: Placebo
Intervention descriptions: intervention 1: 1 pill per day; daily during study participation (up to 84 days) intervention 2: 1 pill per day; daily during study participation (up to 84 days)

Protocol document: