A prospective study to determine the metabolic effects of the contraceptive vaginal ring among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a total of 40 participants and study use of the vaginal ring over a 4-month period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
22
16 weeks of continuous use of contraceptive vaginal ring
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Incidence of Metabolic Syndrome
Metabolic Syndrome defined according to the updated Adult Treatment Panel III as 3 or more of the following criteria: blood pressure ≥130/85 mm Hg, waist circumference \>35 inches, fasting glucose ≥110 mg/dL, TG ≥150 mg/dL, HDL-C \<50 mg/dL.
Time frame: 4 months
Change in low-density lipoprotein (LDL) measure
Time frame: 4 months
Change in high-density lipoprotein (HDL) measure
Time frame: 4 months
Change in triglycerides measure
Time frame: 4 months
Change in apolipoprotein A
Time frame: 4 months
Change in apolipoprotein B
Time frame: 4 months
Change in advanced lipid testing measure
Time frame: 4 months
Change in cholesterol efflux capacity
Time frame: 4 months
Change in fasting insulin level
Time frame: 4 months
Change in fasting 2 hour oral Glucose Tolerance Test result
Time frame: 4 months
Change in Testosterone
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in Ferriman-Gallwey Hirsutism score
A lower score indicates less hirsutism. The F-G scoring system has a minimum value of 0, and a maximum value of 36.
Time frame: 4 months
Body Mass Index
Time frame: 4 months
Change in scoring on the Center for Epidemiologic Studies Depression Scale
The range of values is zero to 60, with the higher scores indicating the presence of more depressive symptoms.
Time frame: 4 months
Change in scoring on the State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory measures both state and trait anxiety, the scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time frame: 4 months
Change in scoring on Polycystic Ovary Syndrome Quality of Life Questionnaire
Worse quality of life is associated with a lower score on the questionnaire, with a range score from 30 to 210.
Time frame: 4 months