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PCOS Clinical Trial NCT03152591

A Clinical Study to Assess an Investigational Drug for Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS), also known as polycystic ovarian syndrome, is a common health problem caused by an imbalance of reproductive hormones. The hormonal imbalance creates problems in the ovaries. The ovaries make the egg that is released each month as part of a healthy menstrual cycle. With PCOS, the egg may not develop as it should or it may not be released during ovulation as it should be.

PCOS can cause missed or irregular menstrual periods. Irregular periods can lead to:

  • Infertility (inability to get pregnant). In fact, PCOS is one of the most common causes of female infertility.
  • Development of cysts (small fluid-filled sacs) in the ovaries

The purpose of the study is to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight & obese women.

If you are eligible and agree to participate in one of the studies, you will be treated with LIK066 or a placebo (a dummy drug with no active medicine, like a sugar pill) over a 2-week period.

Total duration of participation in the study is up to 9 weeks, inclusive of a 6-week screening window and a 1-week follow-up period after treatment.

To see if you may be eligible, click here for a pre-screener / questionnaire. 

Find out if there is a PCOS clinical study location nearby. 

People who participate in this clinical trial must meet the following requirements:

  • Women aged 18 to 40 years who have been categorized as obese
  • Diagnosed with PCOS based on NIH criteria
  • Does not suffer from pre-existing type 1 or type 2 diabetes mellitus, Cushing’s syndrome, congenital adrenal hyperplasia, ovarian or adrenal androgen-secreting tumor, uncontrolled thyroid disease or untreated obstructive sleep apnea
  • Is not pregnant or nursing
  • Does not show exogenous causes of hirsutism
  • No menstruation in the 30 days prior to screening
  • Willing to use basic non-hormonal methods of contraception during dosing of study treatment.

Patients who are eligible and decide to enroll in this trial:

  • Will attend a treatment period of 2 weeks (outpatient visits and one overnight stay at end of treatment)
  • Will not be charged to participate
  • Will receive compensation for time and travel costs
  • May withdraw from the trial at any time, for any reason.

To learn more about Polycystic Ovary Syndrome, also known as PCOS, an autoimmune disorder, click here

Additional study locations may be listed as they open in the future.  We encourage you to share this information via the links at the top of the page.