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

Virginia Commonwealth University (VCU)

Status and phase: Withdrawn; Phase 4

Conditions: Vaginal Bleeding

Treatments: Drug: Estradiol; Drug: Placebo; Drug: Tamoxifen Citrate 10Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT04933240

HM20021901

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Tamoxifen

Active Comparator group

Description:

tamoxifen 10mg daily for 7 days

Treatment:

Drug: Tamoxifen Citrate 10Mg Tab

Estradiol

Active Comparator group

Description:

estradiol 1mg daily for 7 days

Treatment:

Drug: Estradiol

placebo

Placebo Comparator group

Description:

placebo daily for 7 days

Treatment:

Drug: Placebo