Status:
UNKNOWN
Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hyperandrogenemia
Polycystic Ovary Syndrome (PCOS)
Eligibility:
FEMALE
8-18 years
Phase:
NA
Brief Summary
Girls with high levels of the male hormone testosterone often develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, a...
Detailed Description
Adolescent hyperandrogenemia (excess androgen production) occurring before or during early puberty appears to be a precursor to adult polycystic ovary syndrome (PCOS). PCOS affects about 6% of women o...
Eligibility Criteria
Inclusion
- Girls ages 8 to 18
- Hyperandrogenemic (testosterone level \> 0.4 ng/mL and/or hirsutism)
- Normal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
Exclusion
- Abnormal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
- Congenital adrenal hyperplasia.
- Hemoglobin \<12 mg/dL or 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.)
- Weight \< 31 kg
- History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
- On hormonal medications (including oral contraceptive pills) or on medications known to affect the reproductive axis within 3 months of the study
- Pregnant or breastfeeding
- Participation in a research study within the past 30 days that involved taking a study drug.
- Participation in a research study that involved taking up to or greater than 473 ml's of blood within the past 60 days.
- Cigarette smoking
- History of surgery that required bedrest within the past 30 days
- Family history of hypercoagulability or unexplained thromboembolic disease (not in setting of bedrest, surgery, or malignancy)
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01425541
Start Date
April 1 2000
End Date
August 1 2025
Last Update
November 2 2023
Active Locations (1)
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1
Center for Research in Reproduction
Charlottesville, Virginia, United States, 22908