| CTRI Number |
CTRI/2019/06/019879 [Registered on: 26/06/2019] Trial Registered Prospectively |
| Last Modified On: |
01/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial involving patients with Polycystic Ovary Syndrome and to compare the effectivess of Metformin and oral contraceptives given alone or in combination to these patients. |
|
Scientific Title of Study
|
Comparative Study on the Efficacy of Metformin and Oral Contraceptives or either drug alone in Patients with Polycystic Ovary Syndrome (PCOS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Nahida Tabassum |
| Designation |
Professor (Pharmacology) |
| Affiliation |
Department of Pharmaceutical Sciences University of Kashmir Hazratbal Srinagar J&K |
| Address |
Department of Pharmaceutical Sciences University of Kashmir Hazratbal Srinagar J&K
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9419906868 |
| Fax |
|
| Email |
n.tabassum.uk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nazir Ahmad Pala |
| Designation |
Lecturer (Endocrinologist) |
| Affiliation |
Department of Medicine Govt. Medical College Karan Nagar Srinagar |
| Address |
Department of Medicine Govt. Medical College Karan Nagar Srinagar
Srinagar
JAMMU & KASHMIR
190010
India |
| Phone |
7006657011 |
| Fax |
|
| Email |
nazirpala2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maqsood Mohd |
| Designation |
MPharm. Scholar (Pharmacology) |
| Affiliation |
Department of Pharmaceutical Sciences University of Kashmir Hazratbal Srinagar J&K |
| Address |
Department of Pharmaceutical Sciences University of Kashmir Hazratbal Srinagar J&K
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9596545581 |
| Fax |
|
| Email |
maqsood.hurrah@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
SMHS Hospital Srinagar |
| Address |
Karanagar Srinagar 190010
Jammu and Kashmir |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nazir Ahmad Pala |
SMHS Hospital karanagar Srinagar, 190010 Jammu and Kashmir |
Endocrinology section, Room No. 30, Department of Medicine
Srinagar
JAMMU & KASHMIR |
7006657011
nazirpala2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Government Medical College Srinagar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metformin and oral contraceptives (Desogestrel and Ethinyl Estradiol combination) |
Dose of Metformin is 850mg twice daily, Dose of Dsogestrel and Ethinyl Estradiol is 0.15mg and 0.02mg respectively once daily for 21 days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
33.00 Year(s) |
| Gender |
Female |
| Details |
Unmarried females between 18 and 33 years, presenting with characteristics of Polycystic ovary syndrome like, clinical/ biochemical hyperandrogenism or both, ovulatory dysfunction, Polycystic ovaries on ultrasonography (Rotterdam criteria 2003)attending the OPD for consultation in the Endocrinology section, Department of Medicine SMHS Hospital Srinagar will be enrolled during the study period. |
|
| ExclusionCriteria |
| Details |
Patients having thyroid disease,diabetes,adrenal disorders,hyperprolactinemia.
Pregnant women, patients with history of smoking, alcoholism, those with clinically significant cardio vascular disease, renal disease, or hepatic disease are also excluded from this study.
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Metformin and oral contraceptives or monotherapy of either of the drugs in PCOS patients of reproductive age for Restoring menstrual cycle irregularities,Alleviating Clinical and Biochemical hyperandrogenism,Restoring endocrine and metabolic abnormalities.
|
After 3 months
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Metformin and oral contraceptives or monotherapy of either of the drugs in PCOS patients of reproductive age for Restoring menstrual cycle irregularities,Alleviating Clinical and Biochemical hyperandrogenism,Restoring endocrine and metabolic abnormalities.
|
Follow up after 3 months |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Polycystic Ovary Syndrome (PCOS) is a common endocrinopathy among women in their reproductive age that has emerged to become a more frequent event in the 20th century.It was first reported in modern medical literature by Stein and Leventhal who, in 1935, described seven women suffering from amenorrhea, hirsutism, and enlarged ovaries with multiple cysts (Rodgers RJ et al., 2019). According to the European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM), the prevalence is as high as 15–22% in reproductive aged women (Özay AC et al., 2019). Epidemiological studies using the NIH (National institutes of Health) criteria have reported a prevalence of 6.5-8% in women of reproductive age, on the basis of biochemical and/or clinical evidence (Jahangir M et al., 2015). Around 10.97% of Indian female population is suffering from PCOS as compared to 6.3% in Sri Lanka and 2.4% in China (Sharma S and Mishra A 2018). It affects 37.3% of Kashmiri women of Indian subcontinent (Baqai Z et al., 2010). The current definition of PCOS is based on Rotterdam consensus meeting in 2003. It defines the syndrome as presence of any two of the following three criteria: 1) Menstrual disturbance; oligomenorrhoea/anovulation.
2) Clinical and/or biochemical signs of hyperandrogenism like acne, hirsutism etc., after other causes of hyperandrogenism have been ruled out. 3) Ultrasound appearance of polycystic ovaries (Yousouf R et al., 2012). The initial presentation of PCOS is often during the adolescent years; hence, its management deserves special consideration. Symptomatic therapy based on the main complaint remains the treatment of choice for PCOS. Individualized therapy should include oral Contraceptives, antiandrogens, and insulin sensitizing agents. Presently it is being treated by combination pills containing estradiol and progestin which are used in the long-term treatment of PCOS for giving endometrial protection, regularizing menses and improving hirsutism and/or acne by reducing the production of ovarian androgens. Metformin can improve insulin action, and reduce circulating insulin level. A reduction in insulin level can result in an increase in serum hormone-binding globulin and thus reduction in androgen levels (Bobde JA et al., 2014). This study aims to compare the efficacy of Metformin and oral contraceptive pills or either drug alone in PCOS patients of reproductive age. |