DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperandrogenemia; Obesity; Polycystic Ovary Syndrome

Intervention: Leuprolide (Drug); Dexamethasone (Drug); recombinant human chorionic gonadotropin (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
Christine M. Burt Solorzano, MD, Principal Investigator, Affiliation: University of Virginia

Overall contact:
Michelle Y. Abshire, PhD, Phone: 434-243-6911, Email: pcos@virginia.edu

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 (r-hCG).

Clinical Details

Official title: Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration

Secondary outcome: Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration

Eligibility

Minimum age: 7 Years. Maximum age: 18 Years. Gender(s): Female.

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

Locations and Contacts

Michelle Y. Abshire, PhD, Phone: 434-243-6911, Email: pcos@virginia.edu

University of Virginia Center for Research in Reproduction, Charlottesville, Virginia 22908, United States; Not yet recruiting
Christine M. Burt Solorzano, MD, Principal Investigator
John C. Marshall, MD, PhD, Sub-Investigator
Additional Information


Last updated: June 12, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017