Predictors of Hyperandrogenism for Polycystic Ovary Syndrome
(SHK001 Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications that affect the reproductive system, such as birth control pills, metformin, and certain mood stabilizers, at least 2 months before screening and 3 months before the study.
What data supports the effectiveness of the drug ACTH (Adrenocorticotropic hormone) for treating hyperandrogenism in polycystic ovary syndrome?
The research indicates that there is heightened adrenal androgen activity in polycystic ovary syndrome, suggesting that treatments targeting adrenal function, like ACTH, could potentially influence androgen levels. However, the studies do not directly assess the effectiveness of ACTH in treating hyperandrogenism in PCOS.12345
Is the treatment safe for humans?
How does this treatment for PCOS differ from other treatments?
This treatment for PCOS is unique because it focuses on understanding and predicting hyperandrogenism (excess male hormones) by examining adrenal androgen secretion and novel androgen pathways, which are not well understood in current treatments. This approach may offer new insights into managing PCOS by targeting specific hormonal imbalances.25111213
What is the purpose of this trial?
The objective of the study is to determine the relative contributions of four established predictors of hyperandrogenism (luteinizing hormone \[LH\] secretion, ovarian response to recombinant human chorionic gonadotropin \[r-hCG\] administration, adrenal response to adrenocorticotropic hormone \[ACTH\] administration, and hyperinsulinemia) in older vs. young women with Polycystic Ovary Syndrome (PCOS) in a cross-sectional, physiological study. The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS.
Research Team
Chris McCartney, MD
Principal Investigator
University of Virginia
Eligibility Criteria
This trial is for women aged 20-30 and 40-49 with PCOS, showing signs of excess male hormones and irregular periods. They must not be at risk of pregnancy, willing to follow the study plan, and have no history of severe health issues like heart disease or diabetes. Women close to menopause or with certain hormonal disorders are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline measurements including free testosterone, LH concentrations, and glucose tolerance test
Treatment
Administration of ACTH and rhCG to assess hormonal responses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ACTH
- rhCG
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor