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

NCT ID: NCT01422096

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-07-17

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).

Conditions

Hyperandrogenemia; Obesity; Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Leuprolide

Intervention Type: DRUG

depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if \> 37.5 kg im once

Interventions

Leuprolide

depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if \> 37.5 kg im once

Intervention Type: DRUG

Other Intervention Names

Depot Lupron

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Christine Burt Solorzano

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine M. Burt Solorzano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

CBS007

Identifier Type: OTHER

Identifier Source: secondary_id

CBS007

Identifier Type: -

Identifier Source: org_study_id