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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01422096
• Other study ID #: CBS007
• Secondary ID: CBS007
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 1, 2018
• Est. completion date: July 17, 2018

Study information

• Verified date: July 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperandrogenemia
• Hyperandrogenism
• Obesity
• Overweight
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Center for Research in Reproduction	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration		4 weeks after leuprolide
Secondary	Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration		4 weeks after leuprolide