Clinical trial NCT02744131: OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
Official title: OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Metformin
OCP
metabolic parameters
Lead sponsor: Kar Clinic & Hospital Pvt. Ltd.
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: Nova IVI Fertility, New Delhi
name: Dr Patil's Fertility & Endoscopy Clinic, Bangalore
name: Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur
name: University of Messina
First posted: 2016-04-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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 .

Primary outcomes:
measure: Improvements in Menstrual cycle in women with polycystic ovary syndrome.
timeFrame: Six months
measure: Improvement in hirsutism
timeFrame: six months
measure: Improvement in acne score
timeFrame: Six months
measure: Weight loss following treatment
timeFrame: 6months
measure: Reduction in total testosterones
timeFrame: 6months
measure: Reduction in serum fasting insulin
timeFrame: 6 months
measure: Improvements in lipid profile
timeFrame: 6months
measure: Improvement in glucose tolerance
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: KAR clinic and hospital pvt ltd
state: Odisha
Study officials:
References:
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.
citation: 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.
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.