Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

• Status: Completed
• Trial end date: 2019-06-05
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Merck Women's Health Investigator Initiated Studies Program
• Treatments: Contraceptive Agents; Tamoxifen

Criteria

Inclusion Criteria:

• English or Spanish speaking

• women aged 15-45 years of age

• Currently using the ENG-implant for at least 1 month and use proven on exam (palpation of implant at screening visit)

• Willing to continue using the implant for at least 6 months

• >7 days of continuous bleeding/spotting, or 2 or more episodes of bleeding/spotting in the last 30 days.

• Cellphone that is able to receive and respond to a daily text or email message .

Exclusion Criteria:

• Postpartum within six months

• post-abortion within six weeks

• currently pregnant

• currently 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).