Status:
COMPLETED
How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills
Lead Sponsor:
Oregon Health and Science University
Conditions:
Contraceptive Usage
Coagulation
Eligibility:
FEMALE
18-44 years
Phase:
PHASE4
Brief Summary
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 th...
Detailed Description
While the pro-thrombotic effects of estrogens are well established in women using combined oral contraception (COC), controversy exists over whether the various synthetic progestogens (progestins) use...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03418363
Start Date
January 16 2018
End Date
December 11 2019
Last Update
January 23 2020
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239