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.
- Conditions
- Polycystic ovarian syndrome,
- Registration Number
- CTRI/2019/06/019879
- Lead Sponsor
- SMHS Hospital Srinagar
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 120
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.
- 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
SMHS Hospital karanagar Srinagar, 190010 Jammu and Kashmir
🇮🇳JAMMU, & KASHMIR, India
SMHS Hospital karanagar Srinagar, 190010 Jammu and Kashmir🇮🇳JAMMU, & KASHMIR, IndiaDr Nazir Ahmad PalaPrincipal investigator7006657011nazirpala2@gmail.com