Research Study for women with PCOS (Polycystic ovary syndrome)

  • STATUS
    Recruiting
  • participants needed
    100
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Updated on 19 February 2024

Summary

Healthy women ages 18-45 with Polycystic Ovary Syndrome (PCOS) are invited to screen for a study participation in an investigational drug study

Description

This study is researching the effects of the investigational drug, LIK066 and whether it can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). The study drug is not approved for doctors to treat patients with PCOS. Women who are diagnosed with PCOS exhibit excessive amounts or effects of androgenic hormones (like acne, hirsuitism and alopecia) and often associated with obesity, type 2 diabetes mellitus and high cholesterol levels. The symptoms and severity of the syndrome vary greatly among affected women. Your expected participation in this study will last about 9 weeks, with approximately 6 site visits. During this time, you will receive physical exams, laboratory assessments and an ECG. If you qualify for the study, you will have a 50% (1 in 2) chance of receiving LIK066 (50 mg three times daily before breakfast, lunch and dinner), and a 1 in 2 chance of receiving placebo (inactive tablets, sometimes called "sugar pills") three times daily. You will be compensated for your time and travel for participating in this study.

Details
Condition Polycystic ovary disease
Age 18years - 45years
Clinical Study IdentifierTX4847
Last Modified on19 February 2024

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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