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

Study Overview
=================
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.

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

Conditions
-----------------
Vaginal Bleeding

Intervention / Treatment
-----------------
* Drug: Tamoxifen Citrate 10Mg Tab
* Drug: Estradiol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tamoxifen<br>tamoxifen 10mg daily for 7 days | Drug: Tamoxifen Citrate 10Mg Tab<br>* 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.<br>* Other names: NOLVADEX;|
| Active Comparator: Estradiol<br>estradiol 1mg daily for 7 days | Drug: Estradiol<br>* estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.<br>* Other names: ESTRACE;|
| Placebo Comparator: placebo<br>placebo daily for 7 days | Drug: Placebo<br>* A sugar tablet that does not contain any active medicine<br>* Other names: Inactive drug;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of bleeding free 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 | Total number of no spotting or bleeding days | Up to 24 weeks | 
| Days to first re-treatment | Number of days between first and second use of medication | Up to 24 weeks | 
| Total number of re-treatments | Total number of times participant used treatment medication | 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. | 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) | Up to 24 weeks |