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

Virginia Commonwealth University

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Vaginal Bleeding

Interventions

Tamoxifen Citrate 10Mg TabDRUG

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.

EstradiolDRUG

estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.

PlaceboDRUG

A sugar tablet that does not contain any active medicine

Eligibility

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

Medical Language ↔ Plain English

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

Locations (2)

Shanthi Ramesh

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Duration of bleeding free days

Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding

Time frame: Up to 28 days

Secondary Outcomes

Total number of bleeding free days

Total number of no spotting or bleeding days

Time frame: Up to 24 weeks

Days to first re-treatment

Number of days between first and second use of medication

Time frame: Up to 24 weeks

Total number of re-treatments

Total number of times participant used treatment medication

Time frame: Up to 24 weeks

Satisfaction with bleeding

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.

Time frame: Up to 24 weeks

Affects on daily life activities

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)

Time frame: Up to 24 weeks

Data from ClinicalTrials.gov

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