144 Participants Needed

Predictors of Hyperandrogenism for Polycystic Ovary Syndrome

(SHK001 Trial)

MG
Overseen ByMelissa G Gilrain, BS
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The treatment, including recombinant human chorionic gonadotropin (rhCG), was found to be safe and well-tolerated in a study involving 84 healthy men and women. This suggests it is generally safe for human use.678910

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

CM

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

I have PCOS with signs of high male hormones and irregular periods.
I am committed to preventing pregnancy using non-hormonal methods during the study.
Subjects must be willing and able to provide written informed consent
See 3 more

Exclusion Criteria

Your total testosterone level is higher than 150 ng/dL.
I understand what the study involves and why it's being done.
Prisoners
See 26 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements including free testosterone, LH concentrations, and glucose tolerance test

1 day
1 visit (in-person)

Treatment

Administration of ACTH and rhCG to assess hormonal responses

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ACTH
  • rhCG
Trial Overview The study aims to understand how different factors contribute to high male hormone levels in younger vs. older women with PCOS by testing their responses to rhCG (a fertility drug) and ACTH (a hormone that stimulates adrenal glands).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ACTH (Cosyntropin), rhCG (Ovidrel)Experimental Treatment2 Interventions
ACTH (Cosyntropin) administered 250 mcg IV; rhCG (Ovidrel) administered 250 mcg IV

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Findings from Research

Both 'classic' polycystic ovary syndrome (PCO) patients and 'PCO-like' patients show elevated adrenal androgen responses, specifically androstenedione and dehydroepiandrosterone (DHEA), when stimulated with corticotropin-releasing factor (CRF).
Basal levels of DHEA sulfate (DHEA-S) do not effectively predict adrenal responses to CRF, indicating that DHEA-S may not be a reliable marker for adrenal hyperactivity in these patients.
Pituitary-adrenal responses to ovine corticotropin-releasing factor in polycystic ovary syndrome and in other hyperandrogenic patients.Carmina, E., Lobo, RA.[2019]
In a study of 30 women with polycystic ovary syndrome (PCOS), 70% had elevated levels of DHEA sulfate and 53% had elevated 11 beta-hydroxyandrostenedione, indicating significant adrenal androgen excess in this population.
After 3 to 6 months of GnRH agonist therapy, the number of women with elevated DHEA sulfate decreased to 37%, suggesting that the therapy can effectively reduce adrenal androgen levels, particularly in those with initially high levels.
Reassessment of adrenal androgen secretion in women with polycystic ovary syndrome.Carmina, E., Gonzalez, F., Chang, L., et al.[2018]
In a study of 187 non-obese women aged 18-35, higher serum Anti-Mรผllerian hormone (AMH) levels were significantly associated with menstrual disturbances, indicating that AMH could be a useful biomarker for diagnosing PCOS-related menstrual issues.
Women with serum AMH levels greater than 60 pmol/L had a 28.5-fold increased likelihood of experiencing menstrual disturbances compared to those with lower AMH levels, highlighting the potential of AMH in identifying women at risk for PCOS.
Anti-Mรผllerian hormone (AMH) in the Diagnosis of Menstrual Disturbance Due to Polycystic Ovarian Syndrome.Abbara, A., Eng, PC., Phylactou, M., et al.[2021]

References

Pituitary-adrenal responses to ovine corticotropin-releasing factor in polycystic ovary syndrome and in other hyperandrogenic patients. [2019]
Reassessment of adrenal androgen secretion in women with polycystic ovary syndrome. [2018]
Anti-Mรผllerian hormone (AMH) in the Diagnosis of Menstrual Disturbance Due to Polycystic Ovarian Syndrome. [2021]
Increased urinary free cortisol and decreased serum corticosteroid-binding globulin in polycystic ovary syndrome. [2019]
A comparison between the effects of low dose (1 microg) and standard dose (250 microg) ACTH stimulation tests on adrenal P450c17alpha enzyme activity in women with polycystic ovary syndrome. [2022]
First-in-human trial assessing the pharmacokinetic-pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age. [2022]
Adrenal response to adrenocorticotropin stimulation in unexplained infertile women. [2019]
Corticotropin-releasing hormone induces an exaggerated response of adrenocorticotropic hormone and cortisol in polycystic ovary syndrome. [2019]
Androgen responses to adrenocorticotropic hormone infusion among individual women with polycystic ovary syndrome. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Altered cortisol metabolism in polycystic ovary syndrome: insulin enhances 5alpha-reduction but not the elevated adrenal steroid production rates. [2022]
The serum steroid signature of PCOS hints at the involvement of novel pathways for excess androgen biosynthesis. [2023]
Polycystic ovary syndrome: the spectrum of the disorder in 1741 patients. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Implications of Androgen Assay Accuracy in the Phenotyping of Women With Polycystic Ovary Syndrome. [2022]
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