Comparison of effects of three common contraceptive pills, two low estrogen dose and one with higher estrogen and all with different non-androgenic progesterone on metabolic and endocrine parameters in women diagnosed with PCOS
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Lipid profile,free androgen index and basal insulin of non-obese PCOS womenHealth Condition 2: E888- Other specified metabolic disorders
- Registration Number
- CTRI/2018/02/011920
- Lead Sponsor
- Chittaranjan Seva Sadan and Sishu Sadan College of Obstetrics Gynaecology and Child Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Diagnosis of PCOS according to Rotterdam criteria with
Excessive acne
Androgenic alopecia or hirsutism (terminal hair in male pattern distribution) and
Oligomenorrhea (cycles more than 35 days apart but less than 6months apart) or amenorrhea (absence of menstruation for 6-12 months after a cyclic pattern has been established).
Exclusion Criteria
Women with BMI =25
Age=35 years
Smoker
Women with active liver disease
Women with known coagulation disorders
Undiagnosed vaginal bleeding
Women who took OCP in preceding 3months
Amenorrhea for=1year
Women with secondary causes of hyperandrogenism like Cushing syndrome, late onset Congenital adrenal hyperplasia, gross hypothyroidism and hyperprolactinemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of users with TC/HDL and LDL discordance <br/ ><br>Timepoint: 12 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method DL/HDL ratio, HOMA-IR and Free Testosterone level <br/ ><br>, sFG score <br/ ><br>Timepoint: 6month and one year