Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01427595 |
Recruitment Status
:
Active, not recruiting
First Posted
: September 1, 2011
Last Update Posted
: January 23, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome Hyperandrogenism | Drug: Metformin Drug: Progesterone Drug: estrace | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenemic Adolescent Girls (JCM025) |
Actual Study Start Date : | July 22, 2008 |
Estimated Primary Completion Date : | June 28, 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
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)
|
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
Other Name: Estrogen
|
- Change in LH pulse frequency before and after Metformin treatment. [ Time Frame: 12 weeks following start of metformin treatment ]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)).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427595
United States, Virginia | |
Center for Research in Reproduction, University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | John C. Marshall, MD, PhD | University of Virginia |
Responsible Party: | Christine Burt Solorzano, Center for Research in Reproduction, University of Virginia |
ClinicalTrials.gov Identifier: | NCT01427595 History of Changes |
Other Study ID Numbers: |
13789 U54HD028934-18 ( U.S. NIH Grant/Contract ) |
First Posted: | September 1, 2011 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Keywords provided by Christine Burt Solorzano, University of Virginia:
hyperandrogenemia |
Additional relevant MeSH terms:
Polycystic Ovary Syndrome Hyperandrogenism Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases 46, XX Disorders of Sex Development Disorders of Sex Development Urogenital Abnormalities Adrenogenital Syndrome Congenital Abnormalities |
Metformin Estradiol Estrogens Polyestradiol phosphate Progesterone Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Hypoglycemic Agents Physiological Effects of Drugs Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Progestins Contraceptive Agents Reproductive Control Agents |