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

NCT02122380

NCT02122380
Completed Phase 4

Who may be able to join

Who might be able to join this trial:

  • You are a woman between 18 and 40 years old
  • Your body mass index (BMI) is 30 or higher (considered obese range)
  • You have been diagnosed with polycystic ovary syndrome (PCOS) by meeting at least two of these three conditions: irregular or absent periods; signs of higher-than-normal male hormones (such as excess hair growth or elevated testosterone levels, without using hormone therapy or Metformin); or a history of polycystic ovaries confirmed by an ultrasound

Who may not be able to join:

  • You are a current smoker
  • You have Type 1 or Type 2 diabetes, shown by a high fasting blood sugar level at your screening visit or by taking diabetes medication
  • You have high blood pressure that is untreated and above certain levels, or you take blood pressure medication
  • You have a history of low blood sugar episodes
  • You are pregnant or breastfeeding
  • You have had your uterus and both ovaries surgically removed
  • You are currently using hormonal birth control (pill or patch), unless you have stopped at least 8 weeks before the study starts
  • You are currently taking insulin-sensitizing medications such as Metformin, unless you have stopped at least 8 weeks before the study starts
  • You have anemia (low red blood cell levels) found at your screening visit
  • You have a history of heart disease, heart failure, or stroke
  • You have high blood pressure in your lungs (pulmonary hypertension)
  • You have abnormal thyroid, prolactin, or certain hormone levels found at your screening visit
  • Your kidneys are not functioning well enough (confirm with trial site)
  • Your liver is not functioning well enough, shown by certain blood test results
  • You have taken part in another clinical drug trial within the past month
  • You are allergic to any medications used in this study
  • You regularly work night shifts or have an unusual sleep schedule that disrupts your body clock
  • You or a close family member (parent, sibling, or child) has a history of pancreatic cancer
  • You have a personal history of pancreatitis (inflamed pancreas) or known problems with your pancreas
  • You have a blood clotting disorder
  • You regularly take anti-inflammatory painkillers such as ibuprofen, naproxen, or aspirin
  • You have a mental health condition that would prevent you from fully understanding or participating in the study
  • You are unable or unlikely to follow the study requirements or attend all follow-up visits
  • You have any other ongoing condition requiring regular medication that could affect your safety or the study results (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.

Phase 4: approximately Approved of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 4
Sponsor
Vanderbilt University
Registry
clinicaltrials_gov
Start date
1 February 2016
Est. completion
1 August 2019

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean Overnight Growth Hormone Levels

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