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

This study is not yet open for participant recruitment.
Verified December 2016 by Christine Burt Solorzano, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422096
First Posted: August 23, 2011
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia
  Purpose
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).

Condition Intervention
Hyperandrogenemia Obesity Polycystic Ovary Syndrome Drug: Leuprolide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)

Resource links provided by NLM:


Further study details as provided by Christine Burt Solorzano, University of Virginia:

Primary Outcome Measures:
  • 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration [ Time Frame: 4 weeks after leuprolide ]

Secondary Outcome Measures:
  • Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration [ Time Frame: 4 weeks after leuprolide ]

Estimated Enrollment: 20
Study Start Date: June 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Name: Depot Lupron

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422096


Contacts
Contact: Deborah Sanderson 434-243-6911 pcos@virginia.edu
Contact: Christine M. Burt Solorzano, MD 434-243-6911 pcos@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Research in Reproduction Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Deborah Sanderson    434-243-6911    pcos@virginia.edu   
Principal Investigator: Christine M. Burt Solorzano, MD         
Sub-Investigator: John C. Marshall, MD, PhD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Christine M. Burt Solorzano, MD University of Virginia
  More Information

Responsible Party: Christine Burt Solorzano, Assistant Professor of Pediatrics, University of Virginia
ClinicalTrials.gov Identifier: NCT01422096     History of Changes
Other Study ID Numbers: CBS007
CBS007 ( Other Identifier: University of Virginia )
First Submitted: August 19, 2011
First Posted: August 23, 2011
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Overweight
Polycystic Ovary Syndrome
Hyperandrogenism
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Androgens
Leuprolide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents