Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial

May 31, 2022 updated by: Virginia Commonwealth University

Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial

The purpose of this research study is to evaluate the ability of medicines called tamoxifen or estradiol to prevent annoying vaginal bleeding for arm implant users.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This pilot study compares the use of tamoxifen to estradiol to placebo for seven days once a month up to 5 months in contraceptive implant users starting from the time of implant initiation. Participants will record bleeding and satisfaction response in a daily text diary.

Study Type

Interventional

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
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23221
        • Shanthi Ramesh

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:

  • etonogestrel implant users
  • at time of and/or within 21 days of initial use of etonogestrel implant placement
  • must agree not to take additional hormonal therapy during the study trial period

Exclusion Criteria:

  • within 6 months following vaginal or cesarean delivery
  • within 6 weeks following abortion
  • currently breastfeeding
  • positive pregnancy test
  • contraindications to tamoxifen or estrogen
  • history of thromboembolism
  • undiagnosed abnormal uterine bleeding
  • active cervicitis
  • bleeding disorder
  • use of anticoagulation medications
  • an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tamoxifen
tamoxifen 10mg daily for 7 days
Drug: Tamoxifen Citrate 10Mg Tab
nonsteroidal antiestrogen for oral administration in 10 mg tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.
Other Names:
  • NOLVADEX
Active Comparator: Estradiol
estradiol 1mg daily for 7 days
Drug: Estradiol
estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.
Other Names:
  • ESTRACE
Placebo Comparator: placebo
placebo daily for 7 days
Drug: Placebo
A sugar tablet that does not contain any active medicine
Other Names:
  • Inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of bleeding free days
Time Frame: Up to 28 days
Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of bleeding free days
Time Frame: Up to 24 weeks
Total number of no spotting or bleeding days
Up to 24 weeks
Days to first re-treatment
Time Frame: Up to 24 weeks
Number of days between first and second use of medication
Up to 24 weeks
Total number of re-treatments
Time Frame: Up to 24 weeks
Total number of times participant used treatment medication
Up to 24 weeks
Satisfaction with bleeding
Time Frame: Up to 24 weeks
Average satisfaction with bleeding will be assess using daily text surveys. Participants will rate degree of satisfaction with bleeding with the use of symbols (emojis): 1) completely unsatisfied, 2) somewhat unsatisfied, 3) neutral, 4) somewhat satisfied, 5) completely satisfied.
Up to 24 weeks
Affects on daily life activities
Time Frame: Up to 24 weeks
The average affect of bleeding on daily life activities will be assess using daily text surveys. Participants will rate the degree of affects of bleeding on daily life with the use of a visual analogue scale from 0 (no affects) to 100 (highest possible affects)
Up to 24 weeks

Collaborators and Investigators

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

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Frances Casey, MD, MPH, VCU Health System

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 (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20021901

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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