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

Phase 4

Withdrawn

• Conditions: Vaginal Bleeding
• Interventions: Drug: Estradiol; Drug: Placebo; Drug: Tamoxifen Citrate 10Mg Tab

• Registration Number: NCT04933240
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-21
• Status Verified: 2022-05
• Study Start: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-03
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estradiol	Estradiol	estradiol 1mg daily for 7 days
placebo	Placebo	placebo daily for 7 days
Tamoxifen	Tamoxifen Citrate 10Mg Tab	tamoxifen 10mg daily for 7 days

Primary Outcome Measures

Name	Time	Method
Duration of bleeding free days	Up to 28 days	Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding

Secondary Outcome Measures

Name	Time	Method
Total number of re-treatments	Up to 24 weeks	Total number of times participant used treatment medication
Satisfaction with bleeding	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.
Total number of bleeding free days	Up to 24 weeks	Total number of no spotting or bleeding days
Days to first re-treatment	Up to 24 weeks	Number of days between first and second use of medication
Affects on daily life activities	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)

Trial Locations

Locations (2)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Shanthi Ramesh; 🇺🇸 Richmond, Virginia, United States