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Dexamethasone + rhCG for Polycystic Ovary Syndrome (CBS001 Trial)

N/A

Waitlist Available

Led By Christine Burt Solorzano, 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

Girls age 7-18 years

Normal weight (BMI 5-85%-ile for age) or overweight (>85%-ile)

Must not have

Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c >6.5%

Inability to comprehend what will be done during the study or why it will be done

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 60 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying how the ovaries contribute to the production of male hormones in the body during different stages of puberty.

Who is the study for?

This trial is for girls aged 7-18 who may have signs of excess male hormones, like facial hair or irregular periods. They should be normal weight or overweight but not obese and must have normal lab results except for minor variations due to obesity. Girls with certain health conditions or on other research protocols are excluded.

What is being tested?

The study investigates how the ovaries contribute to producing male hormones in adolescent girls at different puberty stages, using medications Dexamethasone and rhCG. This could help understand why some females develop high levels of these hormones.

What are the potential side effects?

Potential side effects from Dexamethasone include increased appetite, mood changes, difficulty sleeping, and higher risk of infections. The use of rhCG might cause pain at the injection site, headaches, fatigue, and hormonal changes.

Eligibility Criteria

Inclusion Criteria

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

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I am a girl aged between 7 and 18.

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My BMI is within the normal or overweight range for my age.

Exclusion Criteria

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

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I have diabetes or my blood sugar/A1c levels are high.

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I understand what the study involves and why it's being done.

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I have a history of congenital adrenal hyperplasia or my 17-hydroxyprogesterone levels are above 300 ng/dL.

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My BMI is below the 5th percentile for my age.

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My thyroid hormone levels are not normal for my age.

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I am obese due to a genetic condition like Prader-Willi syndrome.

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My morning cortisol is low or I have had Cushing syndrome or adrenal issues.

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I am not a boy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Cerebrospinal fluid leak

Deep Vein Thrombosis

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: dexamethasone, rhCG (Ovidrel)Experimental Treatment2 Interventions

rhCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

778 Previous Clinical Trials

1,290,603 Total Patients Enrolled

University of California, San DiegoOTHER

1,170 Previous Clinical Trials

1,571,875 Total Patients Enrolled

Christine Burt Solorzano, MDPrincipal Investigator - University of Virginia Center for Research in Reproduction

UVA Child Development & Rehabilitation Center, University of Virginia Medical Center

University Of Virginia School Of Medicine (Medical School)

Children'S Hosp Of L A (Residency)

7 Previous Clinical Trials

215 Total Patients Enrolled

~6 spots leftby Dec 2025

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