NCT04933240

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Bleeding

Interventions

Type	Name	Description
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.
DRUG	Estradiol	estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.
DRUG	Placebo	A sugar tablet that does not contain any active medicine

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2021-06-21
• Last updated: 2022-06-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study