Status:
TERMINATED
Effects of Androgen Blockade 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
13-17 years
Phase:
NA
Brief Summary
The purpose of this study is to understand the effects of elevated male hormones in adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If the investigators under...
Detailed Description
Similar to women with PCOS, girls with hyperandrogenemia have an increased frequency of LH pulses when compared to age matched controls. An ongoing study by our group is investigating whether the prog...
Eligibility Criteria
Inclusion
- Girls ages 13 to 17
- Tanner IV or V stage of puberty
- Post-menarche
- Hyperandrogenemic (total testosterone \> 0.4 ng/mL or free testosterone \> 35 pmol/L) with or without hirsutism
- Normal aspartate aminotransferase/alanine aminotransferase (AST/ALT) (AST \< 35 U/L, ALT \< 55 U/L)
- 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)
- Elevated AST/ALT (AST \> 35 U/L, ALT \> 55 U/L)
- Hemoglobin \<12 mg/dL or hematocrit \< 36%
- Weight \< 32 kg
- History of liver disease, peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
- Pregnant or breastfeeding
- On medications known to affect the reproductive axis within 3 months of the study (including oral contraceptive pills, metformin, and spironolactone)
- On medications known or likely to inhibit or induce CYP1A2 or CYP3A4 (please see "Restrictions on use of other drugs or treatments" section below for common examples of such drugs)
- Are currently participating in another study or have been in one in the last 30 days.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01428193
Start Date
September 1 2006
End Date
August 1 2017
Last Update
June 4 2018
Active Locations (1)
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1
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, United States, 22908