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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01427595

NCT01427595
Completed Not Applicable

Who may be able to join

Who might be able to join this trial:

  • Girls between the ages of 10 and 17
  • Girls who have higher-than-normal levels of male hormones (specifically a hormone called free testosterone) for their stage of puberty
  • Girls whose kidneys are working well, filtering blood at a healthy rate (confirm with trial site)
  • Girls whose blood count (hemoglobin or hematocrit) is at a normal, healthy level
  • Girls whose routine blood test results are mostly normal, apart from the hormone-related differences expected with high male hormone levels
  • Girls who are sexually active must agree to either abstain from sex or use two forms of barrier contraception (such as condoms) during the study
  • Girls must agree not to take any other medications during the study unless the study doctors give their approval

Who may not be able to join:

  • Girls whose routine blood test results are abnormal (beyond the expected hormone-related differences)
  • Girls whose kidneys are not filtering blood at a healthy enough rate (confirm with trial site)
  • Girls whose blood count is below a healthy level
  • Girls with abnormal liver function based on specific blood tests
  • Girls who weigh less than 34 kg (approximately 75 pounds)
  • Girls who have a history of kidney problems, liver problems, heart failure, blood clots in the veins, or breast, uterine, or cervical cancer
  • Girls who are currently pregnant or breastfeeding
  • Girls who have taken certain hormonal or related medications (such as birth control pills, metformin, or spironolactone) within the last 3 months before the study
  • Girls who are currently in another research study or have participated in one within the last 30 days
  • Girls who are taking certain restricted medications, unless their regular doctor approves stopping them (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
University of Virginia
Registry
clinicaltrials_gov
Start date
18 February 2009
Est. completion
17 January 2015

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Progesterone Sensitivity Index Before and After Metformin Treatment.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov