Status:
COMPLETED
Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Hyperandrogenism
Eligibility:
FEMALE
10-17 years
Phase:
NA
Brief Summary
Many, but not all, girls with high levels of the male hormone testosterone go on to develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess f...
Detailed Description
A better understanding of the factors that make adolescent girls more or less susceptible to the adverse neuroendocrine effects of elevated androgens will hopefully lead to improved prevention and tre...
Eligibility Criteria
Inclusion
- Girls ages 10 to 17
- Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
- Creatinine clearance \> 90 ml/min as calculated by the Cockcroft-Gault equation
- Hemoglobin \> 12 mg/dL or Hematocrit \> 36%
- Normal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
- Sexually active subjects must agree to abstain or use double barrier contraception during the study
- Subjects must agree not to take any other medications during the course of the study without approval by the study investigators.
Exclusion
- Abnormal screening labs (with the exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
- Creatinine clearance less than 90 ml/min as calculated by Cockcroft-Gault equation
- Hemoglobin \<12 mg/dL or hematocrit \< 36%
- Abnormal liver function tests, including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Albumin, and Alkaline Phosphatase
- Weight \< 34 kg
- History of renal dysfunction, liver dysfunction, congestive heart failure, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
- Pregnant or breast feeding
- On medications known to affect the reproductive axis within 3 months of the study (including oral contraceptive pills, metformin, and spironolactone)
- Are currently participating in another study or have been in one in the last 30 days.
- Subjects using restricted medication (see restrictions below) are excluded unless the subject's primary care provider approves stopping the medication.
Key Trial Info
Start Date :
February 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01427595
Start Date
February 18 2009
End Date
January 17 2015
Last Update
January 8 2021
Active Locations (1)
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1
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States, 22908