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

NCT01422096 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: CBS007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration

  4 weeks after leuprolide

Secondary Outcomes (1)

• Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration

  4 weeks after leuprolide

Study Arms (1)

leuprolide

EXPERIMENTAL

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

Drug: Leuprolide

Interventions

Leuprolide DRUG

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

Also known as: Depot Lupron

leuprolide

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• hydroxyprogesterone \>295 ng/dL
• History of Cushing's syndrome or adrenal insufficiency
• Pregnant

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Obesity; Polycystic Ovary Syndrome

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Christine M. Burt Solorzano, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: June 1, 2018
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)