Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

Early Phase 1

Withdrawn

• Conditions: Obesity; Polycystic Ovary Syndrome; Hyperandrogenemia
• Interventions: Drug: Leuprolide

• Registration Number: NCT01422096
• Lead Sponsor: University of Virginia

Brief Summary

This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Study Start: 2018-06-01
• Status Verified: 2018-07
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• overweight (>85th BMI%) females
• Early to late puberty (expected age range 7-18)
• Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
• Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria

• Screening labs outside of age-appropriate normal range
• Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
• Morning Cortisol <5 g/dL
• 17-hydroxyprogesterone >295 ng/dL
• History of Cushing's syndrome or adrenal insufficiency
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
leuprolide	Leuprolide	leuprolide 11.25 mg IM with adrenal suppression/stimulation testing with dexamethasone/Cortrosyn and ovarian stimulation testing with r-hCG before and 3 weeks after injection

Primary Outcome Measures

Name	Time	Method
17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration	4 weeks after leuprolide

Secondary Outcome Measures

Name	Time	Method
Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration	4 weeks after leuprolide

Trial Locations

Locations (1)

University of Virginia Center for Research in Reproduction; 🇺🇸 Charlottesville, Virginia, United States