Know Cancer

or
forgot password

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenemic Adolescent Girls (JCM025)


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

Thank you

Trial Information

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenemic Adolescent Girls (JCM025)


Inclusion Criteria:



- 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 Criteria:

- 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 AST, 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change in LH pulse frequency before and after Metformin treatment.

Outcome Description:

The primary aim will be to compare the change in 11-hour LH pulse frequency between the 1st and the 2nd admissions (Δ(2-1)) to the change in the 11-hour LH pulse frequency between the 3rd and the 4th admissions (Δ(4-3)).

Outcome Time Frame:

12 weeks following start of metformin treatment

Safety Issue:

No

Principal Investigator

John C. Marshall, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

13789

NCT ID:

NCT01427595

Start Date:

July 2008

Completion Date:

April 2015

Related Keywords:

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

Name

Location

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