Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Study Overview
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Brief Summary
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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
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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).

Official Title
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Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Conditions
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Bleeding, Implants, Breakthrough Bleeding

Intervention / Treatment
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* Drug: Tamoxifen
* Drug: Placebo
* Drug: Tamoxifen (open label)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamoxifen<br>Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding | Drug: Tamoxifen<br>* Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study<br>* Other names: Tamifen;Drug: Tamoxifen (open label)<br>* Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study<br>* Other names: Tamifen;|
| Placebo Comparator: Placebo<br>Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding | Drug: Placebo<br>* Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1) | Bleeding free days in the first 30 days | Day 1 to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1. | bleeding free days in the first 90 days | Day 1 to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unscheduled bleeding, Long acting contraception