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Predictors of Hyperandrogenism for Polycystic Ovary Syndrome (SHK001 Trial)
Phase < 1
Recruiting
Led By Chris McCartney, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 minutes and 1 hour after acth
Awards & highlights
SHK001 Trial 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.Check my eligibility
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).See study design
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.
SHK001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am committed to preventing pregnancy using non-hormonal methods during the study.
Select...
I have PCOS with signs of high male hormones and irregular periods.
Select...
I am a woman with PCOS and I am either 20-30 or 40-49 years old.
Select...
I am willing and able to follow the study's schedule and procedures.
SHK001 Trial 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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Corticotropin
Change in calculated free testosterone concentrations
Change in ovarian 17-hydroxyprogesterone to r-hCG
+2 moreSecondary outcome measures
Change in DHEA to ACTH
Change in androstenedione to ACTH
Change in androstenedione to r-hCG
+3 moreSHK001 Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACTH
2013
Completed Phase 4
~150
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,244,929 Total Patients Enrolled
26 Trials studying Polycystic Ovary Syndrome
1,060 Patients Enrolled for Polycystic Ovary Syndrome
Chris McCartney, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
148 Total Patients Enrolled
2 Trials studying Polycystic Ovary Syndrome
148 Patients Enrolled for Polycystic Ovary Syndrome
Su H Kim, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
88 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
88 Patients Enrolled for Polycystic Ovary Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have PCOS with signs of high male hormones and irregular periods.Your total testosterone level is higher than 150 ng/dL.I understand what the study involves and why it's being done.I am committed to preventing pregnancy using non-hormonal methods during the study.I have ongoing liver problems.Your hemoglobin level is lower than 11 grams per deciliter.My hormone levels indicate I am in perimenopause.I have had my uterus and/or both ovaries removed.I have a history of heart or brain blood flow problems.I have a history of heart failure.A close family member has a history of blood clotting disorders.I have had Cushing's syndrome or adrenal insufficiency.I haven't taken any medications that affect the reproductive system in the last 2 months.I am a woman aged 20-30 or 40-49 with PCOS, having irregular or infrequent periods.I have a significant history of lung problems.Your blood has a low level of red blood cells and hemoglobin.I have had a blood clot in my veins or lungs before.Your DHEA-S level is more than 1.5 times the normal range.I have diabetes with high blood sugar or A1c levels.You have a very high body mass index (BMI).I have a history of congenital adrenal hyperplasia or my 17-OHP levels are above 200 ng/dL.My ovaries are enlarged, as confirmed by an ultrasound.You have a high level of prolactin in your blood.I have a history of breast, ovarian, or endometrial cancer.I have a history of blood clotting disorders.Your thyroid stimulating hormone (TSH) levels are not normal.You have had a history of high levels of triglycerides in your blood.Your blood tests show abnormal levels of sodium, potassium, bicarbonate, or creatinine.I am postmenopausal, with no periods for over a year and high FSH levels.I am a woman with PCOS and I am either 20-30 or 40-49 years old.The development of male physical characteristics in a female.I am willing and able to follow the study's schedule and procedures.
Research Study Groups:
This trial has the following groups:- Group 1: ACTH (Cosyntropin), rhCG (Ovidrel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the upper age limit for enrolment into this research beyond eighty years?
"This medical trial exclusively encompasses participants aged 20 to 49."
Answered by AI
To what medical conditions does rhCG offer the most effective relief?
"Nephrotic Syndrome may be treated with rhCG, a medication additionally helpful in treating ophthalmia, sympathetic panhypopituitarism and lupus erythematosus."
Answered by AI
What is the primary goal of this research endeavor?
"This clinical trial seeks to measure the Mean luteinizing hormone (LH) concentrations over a baseline, 30 minutes, and 60 minute period after ACTH administration. Secondary outcomes that will be evaluated include Change in DHEA to ACTH expressed as ng/mL, LH pulse frequency relayed as pulses per hour, and Matsuda index determined by glucose and insulin levels."
Answered by AI
Is it possible to join this research endeavor?
"This study is accepting 144 volunteers with sclerocystic ovaries, ranging from 20 to 49 years of age. The fundamental requirement for potential participants is that they must manifest clinical and/or biochemical hyperandrogenism in combination with either oligomenorrhea (over 45 days between menstrual cycles or fewer than 9 menses per annum) or irregular menstruation. For women aged 40-49 the criteria are slightly altered; less than 10 periods a year (with an average cycle length exceeding 35 days) is acceptable so long as there's a convincing history of oligomenorrhea or inconsistent menstruation."
Answered by AI
What is the current enrollment of participants for this research project?
"Affirmative. As per the clinicaltrials.gov website, this research programme is presently recruiting participants. It was initially published on October 8th 2019 and has been amended as of June 29th 2022; requiring 144 volunteers over a single location to take part in the investigation."
Answered by AI
Is the research team currently seeking participants?
"This clinical trial is still enrolling and has been up-to-date since June 29th 2022, with the initial posting occurring on October 8th 2019."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
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