drugset / Trial / NCT01963403
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
Phase 4
Terminated
26 enrolled
University of California, Davis
Washington University School of Medicine · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2013-12
- Primary completion
- 2015-07
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levonorgestrel | Small molecule | 150 ug | Oral |
| Comparator | ethinyl estradiol | Small molecule | 30 ug | Oral |