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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after administration of rhcg administration
Awards & highlights

CBS001 Trial 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.Check my eligibility
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.See study design
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.

CBS001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a girl aged between 7 and 18.
Select...
My BMI is within the normal or overweight range for my age.

CBS001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after administration of rhcg administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after administration of rhcg administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin (rhCG) administration in normal weight and overweight girls across puberty

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

CBS001 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

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
756 Previous Clinical Trials
1,245,226 Total Patients Enrolled
University of California, San DiegoOTHER
1,126 Previous Clinical Trials
1,552,911 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ovarian Contribution to Androgen Production in Adolescent Girls
Christine Burt Solorzano 2011. "Ovarian Contribution to Androgen Production in Adolescent Girls". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01421810.
All > Uti > Virginia
~8 spots leftby Dec 2025
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