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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by University of Virginia.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia
ClinicalTrials.gov Identifier:
NCT01422096
First received: August 19, 2011
Last updated: June 12, 2012
Last verified: June 2012
  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 (r-hCG).

Condition Intervention
Hyperandrogenemia
Obesity
Polycystic Ovary Syndrome
Drug: Leuprolide
Drug: Dexamethasone
Drug: recombinant human chorionic gonadotropin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration [ Time Frame: 4 weeks after leuprolide ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Arms Assigned Interventions
Experimental: leuprolide
leuprolide dexamethasone r-hCG
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
Drug: Dexamethasone
dexamethasone 1 mg PO twice
Drug: recombinant human chorionic gonadotropin
r-hCG 25 micrograms IV twice
Other Name: Ovidrel

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Genders 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 LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased FSH and/or 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422096

Locations
United States, Virginia
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, United States, 22908
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  CBS002 
Study First Received: August 19, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Leuprolide
BB 1101
Chorionic Gonadotropin
Androgens
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016