Clinical Trial: Diamel in the Treatment of Polycystic Ovary Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome

Brief Summary: The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.

Detailed Summary:
Sponsor: Catalysis SL

Current Primary Outcome:

  • Normalization of blood concentrations of androgens at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations prolactin at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations of estrogens at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations of FSH at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations of LH at week 24 [ Time Frame: 24 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Regularization of the menstrual cycle at week 24. [ Time Frame: 24 weeks ]
  • Reappearance of ovulatory cycles at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations of insulin at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations of cholesterol at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations of triglycerides at week 24 [ Time Frame: 24 weeks ]
  • Normalization of blood concentrations of glucose at week 24 [ Time Frame: 24 weeks ]
  • Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24. [ Time Frame: 24 weeks ]


Original Secondary Outcome: Same as current

Information By: Catalysis SL

Dates:
Date Received: January 15, 2010
Date Started: November 2009
Date Completion:
Last Updated: May 2, 2012
Last Verified: May 2012