Polycystic Ovary SyndromeOCPNCT02744131
OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
A study testing Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate and Metformin 1500mgs per day in people with Polycystic Ovary Syndrome, run by Kar Clinic & Hospital Pvt. Ltd. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate and Metformin 1500mgs per day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- May 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- PCOS Women with BMI ≤ 23
- Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic
- Known diabetic or hypertension .
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
KAR clinic and hospital pvt ltd
Bhubaneswar, Odisha, 751001
Sujata Kar, M.D, +919437824163, suju2463@gmail.com
Suneeta Panigrahi, B.A, womenwing@karhospitals.com
About this study
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:
Read more
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)
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate, Metformin 1500mgs per day
- Keywords
- PCOS, Metformin, OCP, metabolic parameters
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetateDrug
Metformin 1500mgs per dayDrug
| Study group | Role | What they receive |
|---|---|---|
| OCP | Active comparator | Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate. Receives: Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate |
| Metformin | Active comparator | Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily. Receives: Drug: Metformin 1500mgs per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
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.
Measured: six months
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.
Measured: Six months
Weight loss following treatment
Weight loss will be compared between the two arms following 6 months of treatment
Measured: 6months
Reduction in total testosterones
Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment.
Measured: 6months
Reduction in serum fasting insulin
Reduction in insulin levels following treatment will be compared between the two arms
Measured: 6 months
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
Measured: 6months
Improvement in glucose tolerance
75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kar Clinic & Hospital Pvt. Ltd.
- Sponsor type
- University, hospital or 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744131
- Sponsor's protocol ID
- OCP-MET-2016
- Acronym
- OCP
- Status last verified
- Feb 2018
- First submitted
- 20 Mar 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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.
PubMed 23531705Kar 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.
PubMed 26752854Kumar 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.
PubMed 23869152
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
- ClinicalTrials.gov ID
- NCT02744131
- Acronym / sponsor ID
- OCP / OCP-MET-2016
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Metformin, OCP, metabolic parameters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kar Clinic & Hospital Pvt. Ltd.University, hospital or 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
- Study start
- May 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCP | Active comparator | Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetateArm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate. |
| Metformin | Active comparator | Drug: Metformin 1500mgs per dayArm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- PCOS Women with BMI ≤ 23
- Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic
- Known diabetic or hypertension .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate | Drug | OCP |
| Metformin 1500mgs per day | Drug | Metformin |
Primary outcome
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.
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.
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.
Weight loss following treatment
Time frame: 6months
Weight loss will be compared between the two arms following 6 months of treatment
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.
Reduction in serum fasting insulin
Time frame: 6 months
Reduction in insulin levels following treatment will be compared between the two arms
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 23531705Kar 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.
- Background: PubMed 26752854Kar 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.
- Background: PubMed 23869152Kumar 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate and Metformin 1500mgs per day in people with Polycystic Ovary Syndrome, run by Kar Clinic & Hospital Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujata Kar, MD (919437824163, suju2463@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in Menstrual cycle in women with polycystic ovary syndrome. (time frame: Six months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744131, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.