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Effect of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenic Adolescent Girls (JCM021)


N/A
13 Years
17 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Hyperandrogenism

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Trial Information

Effect of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenic Adolescent Girls (JCM021)


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Slope of the percent change in luteinizing hormone (LH) pulses as a function of day 7 progesterone level

Outcome Description:

The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.

Outcome Time Frame:

3 weeks after flutamide treatment

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

12632

NCT ID:

NCT01428193

Start Date:

September 2006

Completion Date:

April 2015

Related Keywords:

  • Polycystic Ovary Syndrome
  • Hyperandrogenism
  • PCOS
  • hyperandrogenemia
  • Polycystic Ovary Syndrome
  • Hyperandrogenism

Name

Location

Center for Research in Reproduction, University of VirginiaCharlottesville, Virginia  22908