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Completed

NCT Number: NCT02903121

Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

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.

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Key information

Conditions

Bleeding Breakthrough Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Implants Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

OHSU

Portland, Oregon, 97239, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tamoxifen

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 first 90 days of the study

Other names: Nolvadex, Genox, Tamifen

Placebo

Drug

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

Other names: Nolvadex, Genox, Tamifen

Primary outcomes

  1. Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)

    Time frame: Day 1 to Day 30

    Bleeding free days in the first 30 days

Secondary outcomes

  1. Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.

    Time frame: Day 1 to Day 90

    bleeding free days in the first 90 days

Other outcomes

  1. Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90

    Time frame: Day 1 of treatment number 4 to Day 90 (second 90 day reference period)

    bleeding free days in the second 90 days

  2. Patient Satisfaction With Bleeding Pattern

    Time frame: Day 1 of treatment 1 to day 180

    Patient satisfaction with bleeding pattern. Assessed by visual analog scale to determine satisfaction with bleeding patterns on a scale of 0-100 mm, where 0 mm represents not satisfied at all and 100 mm is totally satisfied.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: Tamoxifen/BTB

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2016
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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