Trial record 1 of 1 for:    NCT01427595
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Effect of Metformin on Sensitivity of the Gonadotropin-releasing Hormone (GnRH) Pulse Generator to Suppression by Estradiol and Progesterone

This study is currently recruiting participants.
Verified December 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Marshall, University of Virginia
ClinicalTrials.gov Identifier:
NCT01427595
First received: August 30, 2011
Last updated: December 9, 2013
Last verified: December 2013

August 30, 2011
December 9, 2013
July 2008
April 2015   (final data collection date for primary outcome measure)
Change in LH pulse frequency before and after Metformin treatment. [ Time Frame: 12 weeks following start of metformin treatment ] [ Designated as safety issue: No ]
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)).
Same as current
Complete list of historical versions of study NCT01427595 on ClinicalTrials.gov Archive Site
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Effect of Metformin on Sensitivity of the Gonadotropin-releasing Hormone (GnRH) Pulse Generator to Suppression by Estradiol and Progesterone
Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenemic Adolescent Girls (JCM025)

Many, but not all, girls with high levels of the male hormone testosterone go on to develop polycystic ovary syndrome (PCOS) as adults. Women with PCOS often have irregular menstrual periods, excess facial and body hair, and weight gain. PCOS is also a leading cause of difficulty becoming pregnant. The investigators do not understand why some girls with high hormones develop PCOS and others do not. In a previous study by our group, some girls with high levels of male hormones had abnormalities in the secretion of another hormone, called luteinizing hormone (LH), that are often seen in women with PCOS. However, another group had normal LH secretion. The girls with the abnormal LH secretion had higher levels of another hormone, called insulin, than the girls with normal LH secretion. The investigators will test whether metformin, an insulin-sensitizing agent, changes the effects of high male hormone levels in adolescent girls, specifically by looking at their LH secretion response following metformin treatment.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Polycystic Ovary Syndrome
  • Hyperandrogenism
  • Drug: Metformin
    500-2000 mg PO BID (X12 weeks)
  • Drug: Progesterone
    oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2)
  • Drug: estrace
    oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2
Experimental: Metformin, progesterone , estrace
12 weeks Metformin oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (2X) oral estrace, 0.5-1 mg once a day for seven days (2X)
Interventions:
  • Drug: Metformin
  • Drug: Progesterone
  • Drug: estrace
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2015
April 2015   (final data collection date for primary outcome measure)

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 Aspartate Aminotransferase (AST), Alanine Aminotransferase (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.
Female
10 Years to 17 Years
No
Contact: Anne C Gabel, BSc 434-243-6911 pcos@virginia.edu
Contact: John C. Marshall, MD, PhD 434-243-6911 pcos@virginia.edu
United States
 
NCT01427595
13789, U54HD028934-18
No
John Marshall, University of Virginia
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: John C. Marshall, MD, PhD University of Virginia
University of Virginia
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP