NCT01963403

Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive

Relief of Bleeding on the Implant: Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With a Combined Oral Contraceptive: A Placebo-Controlled Randomized Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abnormal Uterine Bleeding, Unspecified
• Uterine Bleeding Heavy

Interventions

Type	Name	Description
DRUG	EE 30mcg/LNG 150mcg	1 pill per day; daily during study participation (up to 84 days)
DRUG	Placebo	1 pill per day; daily during study participation (up to 84 days)

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2013-10-16
• Last updated: 2017-05-12
• Results posted: 2017-05-12

Locations

2 sites across 1 country: United States