Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users (Tamoxifen/BTB)

July 6, 2020 updated by: Alison Edelman, Oregon Health and Science University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Drug: Tamoxifen
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
Drug: Tamoxifen (open label)
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
Placebo Comparator: Placebo
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Drug: Placebo
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

What is the study measuring?

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)
Time Frame: Day 1 to Day 30
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.
Time Frame: Day 1 to Day 90
bleeding free days in the first 90 days
Day 1 to Day 90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 of treatment number 4 to Day 90 (second 90 day reference period)
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.
Day 1 of treatment 1 to day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Merck Women's Health Investigator Initiated Studies Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2017

Primary Completion (Actual)

June 5, 2019

Study Completion (Actual)

June 5, 2019

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU IRB 16519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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