Vaginal Bleeding
Conditions
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.
Interventions
DRUGTamoxifen 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.
DRUGEstradiol
estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.
DRUGPlacebo
A sugar tablet that does not contain any active medicine
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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) |
Countries
United States
Outcome results
None listed