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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
1 pill per day; daily during study participation (up to 84 days)
1 pill per day; daily during study participation (up to 84 days)
University of California, Davis Department of Obstetrics and Gynecology
Sacramento, California, United States
Washington University School of Medicine, Department of Obstetrics and Gynecology
St Louis, Missouri, United States
Number of Participants With Bleeding Improvement
Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.
Time frame: Bleeding improvement will be evaluated during first cycle of study treatment (28 days)
Number of Participants With Adverse Events
Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.
Time frame: Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant
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