Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome; Hyperandrogenism
Intervention: Flutamide (Drug); Progesterone (Drug); estrace (estradiol) (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Virginia
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 understand the effects of elevated male hormones levels in girls, the
investigators may be able to better treat girls with elevated male hormone levels and
perhaps even learn how to prevent the development of PCOS. Females with elevated levels of
male hormones respond differently to estrace (estradiol) and progesterone than females with
normal male hormone levels. The investigators will be giving you estrogen and progesterone
to see how you respond after the male hormone has been blocked by a medication called
flutamide.
Clinical Details
Official title: Effect of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenic Adolescent Girls (JCM021)
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Slope of the percent change in luteinizing hormone (LH) pulses as a function of day 7 progesterone level
Eligibility
Minimum age: 13 Years.
Maximum age: 17 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Center for Research in Reproduction, University of Virginia, Charlottesville, Virginia 22908, United States
Additional Information
Starting date: September 2006
Last updated: December 9, 2013
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