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

NCT05340634

NCT05340634
Completed Phase 4

Who may be able to join

Who might be able to join this trial:

  • You are a woman who has recently been diagnosed with Polycystic Ovary Syndrome (PCOS), with at least 2 of the following: irregular periods (cycles shorter than 21 days, longer than 35 days, any cycle over 90 days, or fewer than 8 periods per year); signs of higher-than-normal male hormones (either through symptoms or blood tests); or an ultrasound showing a specific pattern of cysts or enlarged ovaries
  • You are over 18 years old
  • You are overweight, meaning your Body Mass Index (BMI) is above 25
  • Your prolactin hormone levels (checked by a blood test) are within the normal range
  • You have given written agreement to take part in the trial
  • If you have blood clotting problems or a history of blood clots and cannot take oral contraceptives, you may still be included in the trial, but in a specific group without random assignment (confirm with trial site)

Who may not be able to join:

  • You have been diagnosed with diabetes
  • You have a condition affecting your adrenal glands or any other hormonal disorder
  • You are currently pregnant or breastfeeding
  • You are currently taking a type of medication called SNRIs (a type of antidepressant or nerve pain medication) (confirm with trial site for specific medications)
  • You have another serious illness

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
Margan Biotech
Registry
clinicaltrials_gov
Start date
20 April 2020
Est. completion
2 February 2022

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Change from Baseline in the Mean BMI at 6 Months; Change from Baseline in the Mean Insuline level at 6 Months; Change from Baseline in the Mean Glucose level at 6 Months; Change from Baseline in the Mean Triglycerides at 6 Months; Change from Baseline in the Mean HDL at 6 Months; Change from Baseline in the Mean LDL at 6 Months; Change from Baseline in the Mean AST at 6 months; Change from Baseline in the Mean ALT at 6 months; Change from Baseline in the Mean GGT at 6 months; Change from Baseline in the Mean Bilirubin at 6 Months

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