Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to evaluate the ability of medicines called tamoxifen or estradiol to prevent annoying vaginal bleeding for arm implant users.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Estradiol; Tamoxifen

Criteria

Inclusion Criteria:

• etonogestrel implant users

• at time of and/or within 21 days of initial use of etonogestrel implant placement

• must agree not to take additional hormonal therapy during the study trial period

Exclusion Criteria:

• within 6 months following vaginal or cesarean delivery

• within 6 weeks following abortion

• currently breastfeeding

• positive pregnancy test

• contraindications to tamoxifen or estrogen

• history of thromboembolism

• undiagnosed abnormal uterine bleeding

• active cervicitis

• bleeding disorder

• use of anticoagulation medications

• an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria