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

NCT02568488

NCT02568488
Completed Phase 4

Who may be able to join

Who might be able to join this trial:

  • You are a woman diagnosed with Polycystic Ovary Syndrome (PCOS) and are not currently pregnant.
  • You have a history of irregular or very infrequent periods — for example, cycles longer than 35 days, fewer than 9 periods per year, or no period for more than 12 weeks.
  • You have difficulty getting pregnant along with symptoms such as excess body hair, acne, or higher-than-normal levels of male hormones in your blood.
  • An ultrasound scan has shown signs of polycystic ovaries, such as enlarged ovaries or a higher-than-normal number of small fluid-filled sacs (follicles) on the ovaries.

Who may not be able to join:

  • You have a history of problems managing blood sugar levels or pre-diabetes.
  • You have previously been diagnosed with diabetes during a pregnancy (gestational diabetes).
  • You have been diagnosed with type 2 diabetes.
  • You have a condition called Cushing's syndrome, which involves too much of a stress hormone called cortisol in the body.
  • You have a thyroid condition (an over- or underactive thyroid gland).
  • You have a condition called hyperprolactinemia, which means you have unusually high levels of a hormone called prolactin (confirm with trial site).
  • You have a genetic condition called congenital adrenal hyperplasia, which affects your hormone levels.
  • You are currently taking or have recently taken steroid medications (corticosteroids) for a long period of time.
  • You are taking any other medications that affect your hormones or metabolism, including the contraceptive pill or progesterone-based medications for PCOS.

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
Ahmed Maged
Registry
clinicaltrials_gov
Start date
1 March 2014
Est. completion
1 September 2015

Primary endpoints

hormonal changes

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