Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Society of Family Planning
• Treatments: Contraceptive Agents; Etonogestrel; Tamoxifen

Criteria

Inclusion Criteria:

• Current user of the etonogestrel implant (Nexplanon, Implanon) for at least one month

• Experiencing bleeding episodes more frequently than every 24 days, or a single episode of bleeding lasting longer than 14 days

• English or Spanish speaking

• Planning to continue implant use for six months

• Access to a cell phone that can accept and send text messages

Exclusion Criteria:

• Postpartum within six months

• Post-abortion within six weeks

• Pregnant

• Breast-feeding

• Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant

• Bleeding dyscrasia

• Anticoagulation use

• Active cervicitis

• Allergy to tamoxifen

• History of venous thromboembolism

• Current or past breast or uterine malignancy

• Use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)