OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women

NCT02744131 — Not applicable, Unknown, 100 participants, Kar Clinic & Hospital Pvt. Ltd.

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Registry	NCT02744131, acronym OCP
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Kar Clinic & Hospital Pvt. Ltd. (Other); collaborators: All India Institute of Medical Sciences, Nova IVI Fertility, New Delhi, Dr Patil's Fertility & Endoscopy Clinic, Bangalore, Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur, University of Messina
Conditions	Polycystic Ovary Syndrome
Interventions	Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate, Metformin 1500mgs per day (Drug)
Dates	start 2016-05-01, primary completion 2018-09-01 (estimated), completion 2019-12-01 (estimated), first posted 2016-04-20, last updated 2018-02-05
Locations	1 site in India

-Summary

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.

Intervention:

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)

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+Arms and interventions

Arm	Type	Interventions	Description
OCP	Active comparator	Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate	Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.
Metformin	Active comparator	Drug: Metformin 1500mgs per day	Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.

Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate (Drug)
Metformin 1500mgs per day (Drug)

+Outcome measures

Primary outcomes

Improvements in Menstrual cycle in women with polycystic ovary syndrome. [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 [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 [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 [6months]: Weight loss will be compared between the two arms following 6 months of treatment
Reduction in total testosterones [6months]: Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment.
Reduction in serum fasting insulin [6 months]: Reduction in insulin levels following treatment will be compared between the two arms
Improvements in lipid profile [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 [6months]: 75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups

+Eligibility

Sex: Female, ages: 16 Years to 40 Years

Inclusion Criteria:

* PCOS Women diagnosed by Rotterdam criteria
* Age > 16 or menarche of at least 2 yr upto age 40.
* Diagnosed by Rotterdam Anovulation F.G. Score ≥ 8 or Total testosterone ≥ 40 ngms/dl ovarian volume ≥ 10 cc BMI>23
* Women not attempting pregnancy at present.

Exclusion Criteria:

* PCOS Women with BMI ≤ 23
* Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic
* Known diabetic or hypertension .

+Locations (1)

Facility	City	Country	Status
KAR clinic and hospital pvt ltd	Bhubaneswar, Odisha	India	Recruiting

+Publications

Kar S. Clomiphene citrate or letrozole as first-line ovulation induction drug in infertile PCOS women: A prospective randomized trial. J Hum Reprod Sci. 2012 Sep;5(3):262-5. doi: 10.4103/0974-1208.106338. PMID 23531705
Kar S, Sanchita S. Clomiphene citrate, metformin or a combination of both as the first line ovulation induction drug for Asian Indian women with polycystic ovarian syndrome: A randomized controlled trial. J Hum Reprod Sci. 2015 Oct-Dec;8(4):197-201. doi: 10.4103/0974-1208.170373. PMID 26752854
Kumar P, Nawani N, Malhotra N, Malhotra J, Patil M, Jayakrishnan K, Kar S, Jirge PR, Mahajan N. Assisted reproduction in polycystic ovarian disease: A multicentric trial in India. J Hum Reprod Sci. 2013 Jan;6(1):49-53. doi: 10.4103/0974-1208.112382. PMID 23869152