CTRI/2021/04/032522 [Registered on: 05/04/2021] Trial Registered Prospectively
Last Modified On:
18/07/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Study is to compare combination of product Metformin HCl and Myo-inositol vs Metformin alone in subjects having polycystic ovary syndrome (PCOS).
Scientific Title of Study
A Phase III, double-blind, randomized, multicenter prospective study to evaluate the efficacy and safety of fixed dose combination of Metformin HCl and Myo-inositol as compared to Metformin in subjects with polycystic ovary syndrome (PCOS).
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ECTS/20/001, Version 01, Date: 08 Oct 20
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Milan Satia
Designation
Chief Executive Officer
Affiliation
Ethicare Clinical Trial Services
Address
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad GUJARAT 380015 India
Phone
9825585119
Fax
Email
milansatia@ethicare-cro.com
Details of Contact Person Scientific Query
Name
Dr Milan Satia
Designation
Chief Executive Officer
Affiliation
Ethicare Clinical Trial Services
Address
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Ahmadabad GUJARAT 380015 India
Phone
9825585119
Fax
Email
milansatia@ethicare-cro.com
Details of Contact Person Public Query
Name
Dr Milan Satia
Designation
Chief Executive Officer
Affiliation
Ethicare Clinical Trial Services
Address
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
Clinical Research Department, Ground floor, Ashirwaad Hospital & Research Centre,
Maratha Section, Near JijamataUdyan, Ulhasnagar, Thane, Maharashtra - 421004
Thane MAHARASHTRA
9890328837
omkomsh@rediffmail.com
Dr Neha Maini
Charak Hospital
Ground Floor, Department of Obstetrics &Gynecology, Charak Hospital,Hardoi Rd, near Safed Masjid, Dubagga, Lucknow, Uttar Pradesh 226003 Lucknow UTTAR PRADESH
8853148897
charakhospitalcr@gmail.com
Dr Joydip Paul
College of Medicine and Sagore Dutta Hospital
578 BT Road, Kamarhati, Kolkata, West Bengal-700058, India Kolkata WEST BENGAL
9433257006
jdpaul07@gmail.com
Dr Chinmoyee Sonowal
GNRC Medical
Ground Floor, Room Number 02, Neurology block, GNRC Medical, IIT road, Near IIT shila Grant, Guwahati, Assam, 781031, India. Kamrup ASSAM
8588019749
Chinmoyee35@gmail.com
Dr Archana Sinha
Indira Gandhi institute of Medical Sciences
Department of Obstetrics & Gynaecology, Indira Gandhi institute of Medical Sciences, Sheikhpura, Patna -800014 Patna BIHAR
96615990999
dr.sushant@ymail.com
Dr Shyamala Kaitala
King George Hospital
1St floor, Clinical research room, Rajendra Prasad ward Department of Medicine, King George Hospital, Opp. District, Collector Office, Maharani Peta, Visakhapatnam, Andhra Pradesh 530002 Visakhapatnam ANDHRA PRADESH
9989453046
drshyamalaresearch@gamail.com
Dr Lakshmi Kantha G
Mysore Medical College
1st Floor, Room No. 22, Department of Gynaecology, Mysore Medical College, Irwin Road, next to Railway Staion, Mysuru, Karnataka 570001 Mysore KARNATAKA
9740810611
gdrlakshmikantha@gmail.com
Dr Urvashi Bhatara
NRR Hospital
No.3&3A, Hesarghatta Main Road, Chikkasandra, Next to Janapriya Apartments, Near Chikkabanavara Railway Station, Bangalore-560 090 Bangalore KARNATAKA
7022247227
urvashibhatara@gmail.com
Dr Shalini Srivastava
Om surgical Center and Maternity Home
Ground Floor, Department of OBGY, Room number 203, Om Surgical Center & Maternity Home, SA 17/3 P-4, Sri Krishna Nagar Colony, Paharia, Ghazipur Road, Varanasi - 221007 Varanasi UTTAR PRADESH
9125679980
drshalinivns@gmail.com
Dr Purnima Singh
Pushpanjali Hospital
3rd floor, Gynaecology Department, Pushpanjali Hospital and Research Center, PushpanjaliPalace, Delhi Gate, Agra, Uttar Pradesh 282002 Agra UTTAR PRADESH
8755098432
crc@pushpanjalihospital.in
Dr Piyusha Chandrayan
Sumandeep Hospital
Ground Floor, Room Number 14, Department of Obstetrics & gynaecology, Sumandeep Hospital,H-3/15/40, Kothi Rd, Anandpura, Vadodara, Gujarat 390001 Vadodara GUJARAT
8758747564
piyusha011@gmail.com
Dr Sushma Shah
SVP Institute of medical Science and Research
C2 Wing, 1st floor, Department of Obstetrics & gynaecology,SVP Institute of medical Science,Ellisbridge, Ahmedabad, Gujarat 380006 Ahmadabad GUJARAT
Fixed Dose Combination (FDC) of Metformin HCl(SR) 500 mg and Myo-inositol 600 mg. 1 Tablet BID for 24 weeks.
Comparator Agent
Metforminin
Metforminin (SR) 500 mg 1 tablet BID for 24 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
1.Adult female subjects 18 to40 (both inclusive) years of age.
2.Subject diagnosed of polycystic ovary syndrome (PCOS), according to Rotterdam Criteria, if she has 2 of the following 3 manifestations:
•Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of greater than or equal to 8).
•Disturbed ovulatory function with chronic oligomenorrhea (cycles of > 35 days less than nine cycles per year), or amenorrhea (cycle length > 12 weeks) after negative screening pregnancy test.
•Polycystic ovary as shown by transvaginal ultrasonography (TVUS).
NOTE: As per FIGO recommendation to characterize menstrual irregularities and accordingly, those subjects who are having menstrual cycle of more than 38 days will be included in the study.
3.Subjects with established insulin resistance (by using HOMA IR model, which can be supported by clinical evidences of BMI more than 23 or impaired GTT or cutaneous manifestations like acanthosisnigricans etc.)
4.Subject is willing and able to take oral medications.
5.Subject is willing to continue with regular follow-up as required for the study.
6.Subject willing to observe barrier contraception (oral contraceptives or any other hormonal medications not to be consumed) during the study period.
ExclusionCriteria
Details
1.Pregnant or lactating women (urinary pregnancy test will be applied at screening).
2.Subject with previous medical history (either laboratory or clinical) or currently having any of the following conditions: Cushings syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumours, uncontrolled thyroid disease, hyperprolactinemia or any other hormonal dysfunction.
3.Subject with history or current status of diabetes mellitus, uncontrolled hypertension, symptomatic cardiovascular diseases.
4.Subject with any acute or chronic infections at the time of screening.
5.Subject with history of malignancies.
6.Subject with known history of gynaecological surgery.
7.Subject having impaired renal or liver function at the time of screening.
8.Subject who is currently on a medically-assisted weight loss program with medication or surgical procedures.
9.Subject currently having laparoscopic ovarian diathermy (LOD).
10.Subject who is willing to or currently undergoing in vitro fertilization (IVF), or considering participation in any artificial reproduction techniques (ART) program.
11.Subject who has received or is currently receiving following medication within past 3months of screening: clomiphene citrate; insulin sensitizers like Metformin and thiazolidinediones; aromatase inhibitors like anastrozole, letrozole; glucocorticoids; gonadotropins; gonadotropin-releasing hormone agonists (GnRHa); hormonal contraceptives; antiandrogens like spironolactone, cyproterone acetate (CPA), and flutamide; anti-obesity drugs; or any traditional or herbal medicines.
12.Known history or current use of alcohol, smoker or tobacco user, or Subject with unstable mental illness.
13.Subject is participating or has participated in any other clinical trial within last 30 days prior to screening.
14.In the opinion of the investigator, the Subject is not eligible to participate or may not complythe study procedures.
15.Subject having contraindication or known allergy to any of the study treatment.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Percentage of subjects with improvement in Insulin resistance (HOMA-IR) at 24 weeks of treatment in FDC arm vs. Metformin arm.
2. Percentage of subjects with improvement in menstrual cycle disturbance at 12 and 24 weeks of treatment in FDC arm vs. Metformin arm. (accordance with FIGO recommendations)
24 weeks
Secondary Outcome
Outcome
TimePoints
Changes in serum testosterone levels after 24 weeks of treatment
Changes in systolic and diastolic blood pressure after 24 weeks of treatment
Changes Hip-Waist ratio after 24 weeks of treatment
Changes in BMI after 24 weeks of treatment
Changes in lipid levels (TC, TG, LDL and HDL) after 24 weeks of treatment
Changes in Estradiol/Progesterone/LH/FSH/SHBGafter 24 weeks of treatment
24 weeks
Target Sample Size
Total Sample Size="190" Sample Size from India="190" Final Enrollment numbers achieved (Total)= "173" Final Enrollment numbers achieved (India)="173"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A phase III, double-blind, randomized, multicentre, prospective study to evaluate the efficacy and safety of fixed dose combination of metformin HCl + myo-inositol compared to metformin in subjects with Polycystic Ovary Syndrome (PCOS). Total 190 subjects who are fulfilling inclusion criteria will be enrolled in the study.
Screened subjects will be evaluated and the eligible subjects will be enrolled in the study. The subjects will be followed up for week 6, 12, 18 and 24. The subjects lab parameters were evaluated at week 12 and week 24. The primary endpoint assessment will be percentage of subjects with improvement in insulin resistance and menstrual cycle disturbance at week 24. Secondary endpoint assessment will be change in lab parameters after week 24.