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