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Treatment of obese PCOS in adolescents and young women.

A novel approach to management of obese PCOS in adolescents and young women:towards tailored interventions devoid of conventional oral- contraceptive therapy. A Multicentric Study. - NILL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082746
Enrollment
130
Registered
2025-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Intervention1: combination pharmacotherapy: metformin and antiandrogens and oral semaglutide for 9 months Control Intervention1: Standard therapy: oral contraceptive pills and spironolactone for 9 mon

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adolescents and young women)

Exclusion criteria

Exclusion criteria: Type 2 diabetes mellitus. Patients with thyroid disease Significant systemic disease . Present/recent history of any acute infection or any chronic infection like tuberculosis, hepatitis B and C. Patient suffering from any malignancy Pregnant patients/Postpartum women Planning for pregnancy within next 1 year Individuals with a history of pancreatitis or conditions that predispose them to pancreatitis, such as gallstone disease

Design outcomes

Primary

MeasureTime frame
To assess the PCOS symptom management (eg.Hirsutism, Menstrual irregularities) and androgen profiling before and after treatment in the two treatment groups.Timepoint: Assessment for the period of three years

Secondary

MeasureTime frame
To compare body weight, body composition and Insulin resistance in adolescents before and after treatment in the two groups. Timepoint: Assessment for the period of three years;Investigate Epigenetic Changes before and after treatment in the two treatment arms. Timepoint: Assessment for the period of three years;Compare bone health through DXA, bone turnover markers and HRpQCT before and after treatment in the two treatment groupsTimepoint: Assessment for the period of three years

Countries

India

Contacts

Public ContactDr Rama Walia

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

ramawalia@rediffmail.com9872997438

Outcome results

None listed

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