Phase 3 Ovarian Cancer Trial, Recruiting NCT05819853 Sponsor: University of Colorado, Denver Condition: Ovarian Cancer
Back to Ovarian Cancer

Phase 3 Ovarian Cancer Trial, Recruiting

NCT05819853
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are female
  • You are between 12 and 35 years old
  • You exercise less than 2 hours per week of moderate activity (such as jogging or swimming)
  • You have irregular or infrequent periods, with or without taking metformin, as defined by international PCOS guidelines
  • If you are under 18, your BMI is at or above the 95th percentile for your age; if you are 18–35, your BMI is 30 or higher, OR your BMI is 27 or higher AND you have at least one weight-related health condition such as high blood pressure or high cholesterol
  • Your weight has stayed within 5 kg (about 11 lbs) of the same weight for the past 3 months
  • You have been diagnosed with PCOS based on specific medical criteria, including irregular periods and higher-than-normal testosterone levels
  • You are not using hormonal birth control and are willing to either avoid sex or use non-hormonal contraception (such as a copper IUD) for the entire study
  • If joining the metformin + semaglutide group, you have been taking at least 1,500 mg of metformin daily for at least 3 months before the study screening

Who may not be able to join:

  • You or a close family member has been diagnosed with a specific type of thyroid cancer (medullary thyroid carcinoma) or a related condition called Multiple Endocrine Neoplasia type 2 (MEN2), or a thyroid nodule was found during your screening exam (confirm with trial site)
  • You are currently taking certain medications that affect how your body handles blood sugar, including some steroids, certain antipsychotics, immune-suppressing drugs, HIV medications, hormonal contraceptives, weight loss medications, or other GLP-1 medications (specific timing restrictions apply — confirm with trial site)
  • You have used weight loss medications in the past 6 months
  • You are currently pregnant or breastfeeding
  • You have been seriously ill and needed to be hospitalised in the past 60 days
  • You have diabetes, based on a specific blood test result (HbA1c of 6.5% or higher)
  • You have anaemia, based on a specific blood test result (confirm with trial site)
  • You have a significant psychiatric or developmental condition that would make it difficult to give informed consent
  • You have a known liver disease (other than fatty liver disease), or your liver test results are significantly elevated
  • You have a personal history of pancreatitis (inflammation of the pancreas)
  • You have known kidney disease, or your kidney function test result is below a certain level
  • You have a history of serious digestive conditions such as gastroparesis (slow stomach emptying)
  • You have a history of gallstones
  • You have a thyroid condition that is not being treated
  • You have had an allergic reaction to semaglutide in the past
  • Your high testosterone or irregular periods are caused by something other than PCOS, such as a tumour or another hormonal condition
  • You are currently being treated for or are experiencing active symptoms of anorexia nervosa or a binge/purge eating disorder
  • You are hoping to become pregnant within the next 12–18 months
  • You have previously had bariatric (weight loss) surgery
  • You use THC (cannabis, whether smoked or eaten) more than 3 days per week
  • You drink more than 2 alcoholic drinks on more than 3 days per week
  • You are unwilling or unable to commit to using appropriate non-hormonal contraception throughout the study

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Melanie Cree-Green, MD,PhD, University of Colorado Anschutz/Children's Hospital Colorado

Phone: 720-777-6984

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
3 November 2023
Est. completion
1 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in ovulation frequency before and after semaglutide in females with PCOS

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: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov