drugset / Trial / NCT02903121
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Phase 4
Completed
109 enrolled
Oregon Health and Science University
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women. The only study to demonstrate a sustained reduction in bleeding lasting for two months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary data of tamoxifen and ENG implant users, the investigators plan to perform additional studies on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.
Timeline
- Start
- 2017-01-20
- Primary completion
- 2019-06-05
- Completion
- 2019-06-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tamoxifen | Small molecule | 10 mg | Oral |