Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Oregon Health and Science University109 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

109

Conditions

Bleeding Implants

Interventions

TamoxifenDRUG

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

PlaceboDRUG

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

Tamoxifen (open label)DRUG

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

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Time frame: Day 1 to Day 30

Secondary Outcomes

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

Time frame: Day 1 to Day 90