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

Abnormal Uterine Bleeding, Unspecified Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding, Unspecified
• Hemorrhage
• Uterine Bleeding Heavy
• Uterine Hemorrhage

• NCT number: NCT01963403
• Study type: Interventional
• Source: University of California, Davis
• Status: Terminated
• Phase: Phase 4
• Start date: December 2013
• Completion date: September 2015