Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Phase 4

Completed

• Conditions: Bleeding; Implants; Breakthrough Bleeding
• Interventions: Drug: Tamoxifen; Drug: Placebo; Drug: Tamoxifen (open label)

• Registration Number: NCT02903121
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

The investigators will perform a 2 phase trial for treatment of women experiencing frequent or prolonged bleeding while using the ENG contraceptive implant. The first phase will consist of a randomized, controlled, double blind placebo-controlled clinical trial over a 90-day reference period and the second phase will allow both study arms to receive open-label treatment over an additional 90-day reference period. The primary outcome of the study will be the total number of consecutive bleeding-free days in first 30 days from Day 1 of first treatment (TX1).

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-16
• Study Start: 2017-01-20
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Results First Submitted: 2020-06-02
• Results First Submitted QC: 2020-06-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Results First Posted: 2020-07-07
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamoxifen	Tamoxifen	Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen	Tamoxifen (open label)	Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo	Placebo	Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding

Primary Outcome Measures

Name	Time	Method
Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)	Day 1 to Day 30	Bleeding free days in the first 30 days

Secondary Outcome Measures

Name	Time	Method
Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.	Day 1 to Day 90	bleeding free days in the first 90 days

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States