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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
Nova IVI Fertility, New Delhi
Dr Patil's Fertility & Endoscopy Clinic, Bangalore
Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur
University of Messina
Information provided by (Responsible Party):
Kar Clinic & Hospital Pvt. Ltd.

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)


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Weight loss following treatment [ Time Frame: 6months ]
    Weight loss will be compared between the two arms following 6 months of treatment

  5. 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.

  6. Reduction in serum fasting insulin [ Time Frame: 6 months ]
    Reduction in insulin levels following treatment will be compared between the two arms

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

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


Contacts
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Contact: Sujata Kar, MD 919437824163 suju2463@gmail.com

Locations
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India
KAR clinic and hospital pvt ltd Recruiting
Bhubaneswar, Odisha, India, 751001
Contact: Sujata Kar, M.D    +919437824163    suju2463@gmail.com   
Contact: Suneeta Panigrahi, B.A       womenwing@karhospitals.com   
Sponsors and Collaborators
Kar Clinic & Hospital Pvt. Ltd.
All India Institute of Medical Sciences, New Delhi
Nova IVI Fertility, New Delhi
Dr Patil's Fertility & Endoscopy Clinic, Bangalore
Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur
University of Messina
Publications:
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Responsible Party: Kar Clinic & Hospital Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02744131    
Other Study ID Numbers: OCP-MET-2016
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Kar Clinic & Hospital Pvt. Ltd.:
PCOS
Metformin
OCP
metabolic parameters
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Cyproterone Acetate
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Cyproterone
Hypoglycemic Agents
Physiological Effects of Drugs
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male