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.

Comparative Study on the Efficacy of Metformin and Oral Contraceptives or either drug alone in Patients with Polycystic Ovary Syndrome (PCOS)

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/06/019879

Enrollment

120

Registered

2019-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Control Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. Timepoint: After 3 months	—

Secondary

Measure	Time frame
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. Timepoint: Follow up after 3 months	—

Countries

India

Contacts

Public ContactMaqsood Mohd

Department of Medicine Govt. Medical College Karan Nagar Srinagar

nazirpala2@gmail.com7006657011

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026