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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 24 hours after administration of rhcg administration
Awards & highlights

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.

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 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 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
EPISTAXIS
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
DIABETES MELLITUS
6%
NEUROPATHY PERIPHERAL
6%
DECUBITUS ULCER
6%
CANCER PAIN
6%
PERIPHERAL SENSORY NEUROPATHY
6%
HEADACHE
6%
CYSTITIS
6%
WEIGHT INCREASED
6%
GASTROENTERITIS
6%
INCREASED APPETITE
6%
RESTLESSNESS
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMONIA PNEUMOCOCCAL
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
MULTI-ORGAN FAILURE
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone

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
761 Previous Clinical Trials
1,255,958 Total Patients Enrolled
University of California, San DiegoOTHER
1,135 Previous Clinical Trials
1,551,164 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
~7 spots leftby Dec 2025