Back to resultsEffect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Primary Purpose
Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Leuprolide
Sponsored by
About this trial
This is an interventional basic science trial for Hyperandrogenemia
Eligibility 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
Sites / Locations
- University of Virginia Center for Research in Reproduction
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
leuprolide
Arm Description
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
Outcomes
Primary Outcome Measures
17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration
Secondary Outcome Measures
Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01422096
Brief Title
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Official Title
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study team decided not to pursue this study.
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
July 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
leuprolide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Leuprolide
Other Intervention Name(s)
Depot Lupron
Intervention Description
depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if > 37.5 kg im once
Primary Outcome Measure Information:
Title
17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration
Time Frame
4 weeks after leuprolide
Secondary Outcome Measure Information:
Title
Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration
Time Frame
4 weeks after leuprolide
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M. Burt Solorzano, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Research in Reproduction
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
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