Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Completed · Phase 4 · Has a placebo group

Conditions studied: Bleeding, Implants, Breakthrough Bleeding

In brief

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.

Key facts

Study ID

NCT02903121

Run by

Oregon Health and Science University

People needed

109

Starts

2017-01-20

Expected to finish

2019-06-05

Last updated by the study team

2020-07-15

Who can join

Age: 15 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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 .

You may not qualify if…

• 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).

Where it is running

• OHSU — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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