A study involving comparison of the efficacy of Tamoxifen Vs Letrozole - two hormonal based drugs in treatment of male breast enlargement

A Comparative study to assess efficacy of Tamoxifen and Letrozole in Pubertal gynecomastia - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066186

Enrollment

Registered

2024-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: E898- Other postprocedural endocrine andmetabolic complications and disorders

Interventions

Intervention1: Tablet Tamoxifen Citrate Tablet Letrozole: Tablet Tamoxifen Citrate 10 mg twice daily daily for maximum of 6 months Tablet Letrozole 2.5 mg once daily for maximum 6 months Compariso

Eligibility

Inclusion criteria

Inclusion criteria: Pubertal gynecomastia of less than 6 months onset

Exclusion criteria

Exclusion criteria: All Pathological and secondary causes of gynecomastia - Hypogonadism - Drug Induced - Anabolic steroid abuse Gr IV Pubertal gynecomastia

Design outcomes

Primary

Measure	Time frame
1)To assess the treatment response i.e. complete and partial regression of Gynecomastia by the percentage change in volume of gynecomastia 2)To determine the proportion of patients with resolution of Breast pain in relation to time interval and age of the patient Timepoint: 6 months	—

Secondary

Measure	Time frame
To correlate the association between Pubertal gynecomastia and Hormone levels ( Total and free Testosterone , Estradiol,Testosterone/Estradiol (T/E2) ratioTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDr.S.Sridhar

Madurai Medical college

drsridharjipmer@gmail.com9789720246

Outcome results

None listed

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