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Predictors of Hyperandrogenism for Polycystic Ovary Syndrome (SHK001 Trial)

Phase < 1

Recruiting

Led By Su H Kim, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study

Subject is considered to have PCOS if she has current or verifiable history of: clinical and/or biochemical evidence of hyperandrogenism plus oligomenorrhea or irregular menstruation

Must not have

Persistent liver abnormalities

Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone <0.5 ng/mL or cycle day 3 FSH > 9 IU/L (with concomitant estradiol level >80 pg/mL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 30 minutes and 1 hour after acth

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well four established predictors of hyperandrogenism work in older and younger women with PCOS.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Potential side effects from rhCG may include abdominal pain, swelling, shortness of breath, diarrhea, nausea or vomiting. ACTH can cause allergic reactions, increased blood pressure, changes in mood or behavior, electrolyte imbalances and muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am committed to preventing pregnancy using non-hormonal methods during the study.

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I have PCOS with signs of high male hormones and irregular periods.

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I am a woman with PCOS and I am either 20-30 or 40-49 years old.

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I am willing and able to follow the study's schedule and procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ongoing liver problems.

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My hormone levels indicate I am in perimenopause.

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I have had my uterus and/or both ovaries removed.

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I have a history of heart or brain blood flow problems.

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I have a history of heart failure.

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A close family member has a history of blood clotting disorders.

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I have had Cushing's syndrome or adrenal insufficiency.

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I have a significant history of lung problems.

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I have had a blood clot in my veins or lungs before.

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I have diabetes with high blood sugar or A1c levels.

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I have a history of congenital adrenal hyperplasia or my 17-OHP levels are above 200 ng/dL.

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My ovaries are enlarged, as confirmed by an ultrasound.

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I have a history of breast, ovarian, or endometrial cancer.

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I have a history of blood clotting disorders.

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I am postmenopausal, with no periods for over a year and high FSH levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 mininutes and 1 hour after adrenocorticotropic hormone (acth), 24 hours after recombinant human chorionic gonadotropin (rhcg).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 30 mininutes and 1 hour after adrenocorticotropic hormone (acth), 24 hours after recombinant human chorionic gonadotropin (rhcg).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 mininutes and 1 hour after adrenocorticotropic hormone (acth), 24 hours after recombinant human chorionic gonadotropin (rhcg). for reporting.