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

Polycystic Ovary Syndrome Clinical Trial

— OCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02744131
• Other study ID #: OCP-MET-2016
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2016
• Last updated: February 1, 2018
• Start date: May 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: Kar Clinic & Hospital Pvt. Ltd.
• Contact: Sujata Kar, MD
• Phone: 919437824163
• Email: suju2463[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate

• Metformin 1500mgs per day

Locations

Country	Name	City	State
India	KAR clinic and hospital pvt ltd	Bhubaneswar	Odisha

Sponsors (6)

Lead Sponsor	Collaborator
Kar Clinic & Hospital Pvt. Ltd.	All India Institute of Medical Sciences, New Delhi, Dr Patil's Fertility & Endoscopy Clinic, Bangalore, Nova IVI Fertility, New Delhi, Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur, University of Messina

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in Menstrual cycle in women with polycystic ovary syndrome.	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.	Six months
Primary	Improvement in hirsutism	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.	six months
Primary	Improvement in acne score	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.	Six months
Primary	Weight loss following treatment	Weight loss will be compared between the two arms following 6 months of treatment	6months
Primary	Reduction in total testosterones	Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment.	6months
Primary	Reduction in serum fasting insulin	Reduction in insulin levels following treatment will be compared between the two arms	6 months
Primary	Improvements in lipid profile	Any improvement in triglycerides and HDLc (high density lipoprotein c) will be compared between the two groups after 6 months of treatment	6months
Primary	Improvement in glucose tolerance	75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups	6months