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 (ROBI)

NCT01963403 Phase 4 TERMINATED Results posted

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

Details

Lead sponsor	University of California, Davis
Phase	Phase 4
Status	TERMINATED
Enrolment	26
Start date	2013-12
Completion	2015-09

Conditions

• Abnormal Uterine Bleeding, Unspecified
• Uterine Bleeding Heavy

Interventions

• EE 30mcg/LNG 150mcg
• Placebo

Primary outcomes

• Number of Participants With Bleeding Improvement — Bleeding improvement will be evaluated during first cycle of study treatment (28 days)
  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.

Countries

United States