Clinical Trial: Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism

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

Official Title: Positive Clinical and Hormonal Effects of Ethinylestradiol Combined With Drospirenone (EE/DRSP) in Women With Polycystic Ovary Syndrome (PCOS): Impact of Body Weight and Relevance to

The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units.

FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100



Original Primary Outcome: Biochemical Assessment of Hyperandrogenism [ Time Frame: 24 weeks ]

The primary outcome measures are changes pre and post-treatment in free androgen index {[FAI = testosterone concentration (nmol/l)/ concentration of sex hormone binding globulin [SHBG (nM/L) x100] and adrenal androgen levels of dehydroepiandrosterone sulfate


Current Secondary Outcome:

  • Cardiometabolic Measures [ Time Frame: 24 weeks ]
    Values represent blood pressure at 24 weeks.
  • Post Therapy BMI. [ Time Frame: 24 weeks ]
    Post-treatment body mass index at 24 weeks
  • Biochemical Indicator of B-vitamin Status [ Time Frame: 24 weeks ]
    Post-treatment in folate concentrations after 24 weeks of treatment
  • Menstrual Cycle Regularity [ Time Frame: 24 weeks ]
    Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..
  • Adrenal Androgen DHEAS [ Time Frame: 24 weeks ]
    Post-treatment levels of adrenal androgen DHEAS
  • Oral Disposition Index [ Time Frame: 24 weeks ]
    Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism


Original Secondary Outcome:

  • Cardiometabolic Measures [ Time Frame: 24 weeks ]
    Changes pre and post-treatment in blood pressure, lipid profiles and indexes of glucose tolerance and insulin sensitivity
  • anthropometric measures [ Time Frame: 24 weeks ]
    Changes pre- and post-treatment in body mass index, absolute body weight, abdominal adiposity [waist and waist: hip ratio]
  • Biochemical Indicator of B-vitamin Status [ Time Frame: 24 weeks ]
    Changes pre- and post-treatment in folate and vitamin B12 concentrations
  • menstrual cycle regulation [ Time Frame: 24 weeks ]
    Changes in menstrual cyclicity as determined by # menses/24 weeks pre- and post-treatment


Information By: Woman's

Dates:
Date Received: May 25, 2011
Date Started: August 2011
Date Completion:
Last Updated: March 30, 2017
Last Verified: March 2017