How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills
Completed · Phase 4 · Has a placebo group
Conditions studied: Contraceptive Usage, Coagulation
In brief
A randomized study is to learn more about how a supplement called DHEA (dehydroepiandrosterone) affects clotting factors in women taking combined oral contraceptive pills. Current research suggests that the progestin hormone in a specific type of birth control pill may increase a woman's blood clot risk. However, it is unknown exactly how the progestin causes the increased risk. This study aims to learn if taking a daily dose of supplemental androgen (dehydroepiandrosterone, or DHEA) in addition to birth control pills containing DRSP affects proteins related to coagulation.
Key facts
- Study ID
- NCT03418363
- Run by
- Oregon Health and Science University
- People needed
- 15
- Starts
- 2018-01-16
- Expected to finish
- 2019-12-11
- Last updated by the study team
- 2020-01-23
Who can join
Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women of reproductive age (18-44 years) in generally good health and with body mass index (BMI) between 18 and 35kg/m2
- Premenopausal, with uterus and at least one ovary intact
- Current users (at least 3 months) of combined oral contraception consisting of 0.02 mg (milligram) ethinyl estradiol and 3 mg drospirenone
- Willing to continue use of current combined oral contraception for the next three menstrual cycles
- Have a prescription for combined oral contraception consisting of ethinyl estradiol and drospirenone for the next four cycles
- Not currently using androgen supplementation
- Willing and able to sign the informed consent
- Willing to comply with the study requirements and visit schedule
- No desire to conceive during study participation, approximately 3 months
You may not qualify if…
- Currently enrolled in another clinical trial
- Contraindications to androgen supplementation; history of polycystic ovarian syndrome (PCOS)
- Known or suspected pregnancy, pregnancy within 3 months before study enrollment, or desire to conceive during study participation
- Currently breastfeeding
- Known or suspected alcoholism or drug abuse
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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