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To analyse if T.Metformin along with lifestyle modification is better than only lifestyle modification is treatment of adolescent PCOS.

Comparision of effect of tablet metformin with lifestyle modification and placebo with lifestyle modification on adolescent PCOS - A RANDOMOZED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058811
Enrollment
90
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: N915- Oligomenorrhea, unspecified

Interventions

Intervention1: Drug tablet Metformin: 500mg, per oral, twice daily (BD), for 3months Control Intervention1: Drug tablet Iron suppliments: Per oral, twice daily, Given for a period of 3 months

Sponsors

Sri Manakula vinayagar medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Irregular cycle, clinical hyperandrogenism, biochemical hyperandrogenism

Exclusion criteria

Exclusion criteria: Primary amenorrhea due to structural deformities, regular cycle, gastritis, gastric ulcer, liver disease, depression or bipolar disorder, contraindication to exercise.

Design outcomes

Primary

MeasureTime frame
To assess the effect of tablet metformin on biochemical parameters like lutenizing hormone, toral testosterone, lipid profile, HbA1C in adolescent PCOS.Timepoint: 3months

Secondary

MeasureTime frame
To compare the effect of tablet metformin and lifestyle modification versus placebo and lifestyle modification for 3months in regularising the menstural cycles, reducing hirsutism, acne and obesity in adolescent PCOSTimepoint: 3months

Countries

India

Contacts

Public ContactJedidiah JF

Sri manakula vinayagar medical college and hospital

niveog91@yahoo.com9080128257

Outcome results

None listed

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