Effects of Androgen Administration on Inflammation in Normal Women
Completed · Not applicable · Has a placebo group
Conditions studied: Hyperandrogenism
In brief
The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.
Key facts
- Study ID
- NCT01753037
- Run by
- Mayo Clinic
- People needed
- 25
- Starts
- 2006-12-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2013-11-18
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Acceptable health based on interview, medical history, physical examination and lab tests
- Ability to comply with requirements of the study
- Ability and willingness to provide signed, witnessed informed consent
- Between the ages of 18-40 years
- Body mass index between 18 and 25
- Normal regular monthly periods
- No clinical evidence of androgen excess
- No evidence of polycystic ovaries on ultrasound
You may not qualify if…
- Diabetes mellitus
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease
- High blood pressure
- Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.)
- Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations
- Known hypersensitivity to DHEA
- Two first-degree relatives with breast cancer or ovarian cancer
- Documented or suspected history of recent (within 1 year) illicit drug abuse or alcoholism
- Tobacco smoking
- Ingestion of any investigational drugs within 4 weeks prior to study onset
- Pregnancy or lactation (less than or equal to 6 weeks postpartum)
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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