OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women (OCP)
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|ClinicalTrials.gov Identifier: NCT02744131|
Recruitment Status : Unknown
Verified February 2018 by Kar Clinic & Hospital Pvt. Ltd..
Recruitment status was: Recruiting
First Posted : April 20, 2016
Last Update Posted : February 5, 2018
Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E&P cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS( polycystic ovary syndrome)women from India.
Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference, Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks), Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid Profile, FAsting blood sugar & 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25- hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays)
Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood sugar); GTT(glucose tolerance test)
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate Drug: Metformin 1500mgs per day||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2019|
Active Comparator: OCP
Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.
Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate
Active Comparator: Metformin
Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.
Drug: Metformin 1500mgs per day
- Improvements in Menstrual cycle in women with polycystic ovary syndrome. [ Time Frame: Six months ]To compare improvement in Menstrual cycle. Women will be required to maintain a menstrual calendar for the duration of the study and asked to fill a questionnaire before and after study duration.The questionnaire will cover menstrual cycle dates, duration and amount. Interpreting the answered will help in assessing improvement in menstrual pattern.
- Improvement in hirsutism [ Time Frame: six months ]FG scores before and after treatment will be compared between the two arms. Modified Ferriman and Gallwey visual score will be used by a nurse to assess before and after the study period.
- Improvement in acne score [ Time Frame: Six months ]Acne scores before and after treatment will be compared between the two arms. Visual assessment of acne using "mild/moderate/severe " grades will be assessed before and after study by a physician.
- Weight loss following treatment [ Time Frame: 6months ]Weight loss will be compared between the two arms following 6 months of treatment
- Reduction in total testosterones [ Time Frame: 6months ]Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment.
- Reduction in serum fasting insulin [ Time Frame: 6 months ]Reduction in insulin levels following treatment will be compared between the two arms
- Improvements in lipid profile [ Time Frame: 6months ]Any improvement in triglycerides and HDLc (high density lipoprotein c) will be compared between the two groups after 6 months of treatment
- Improvement in glucose tolerance [ Time Frame: 6months ]75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744131
|Contact: Sujata Kar, MDfirstname.lastname@example.org|