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

NCT01422096 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2018-07-19

No results posted yet for this study

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

Interventions

DRUG

Leuprolide

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

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Christine M. Burt Solorzano, MD · University of Virginia

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-07-17
Completion
2018-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422096 on ClinicalTrials.gov