EFFICACY OF ORAL ORMELOXIFENE VERSUS VITAMIN E ON MASTALGIA

EFFICACY OF ORAL ORMELOXIFENE VERSUS VITAMIN E ON MASTALGIA: AN OPEN LABEL RANDOMISED CONTROLLED STUDY - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083396

Enrollment

Registered

2025-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: E35- Disorders of endocrine glands in diseases classified elsewhere

Interventions

Intervention1: Vitamin E: Vitamin E was given to patients 400mg daily dosing for 3 months Control Intervention1: Ormeloxifene: Ormeloxifene 30mg was given to patients on alternate days for 3 months

Eligibility

Inclusion criteria

Inclusion criteria: Para 1 or above, non-desirous of pregnancy in recent future

Exclusion criteria

Exclusion criteria: Multiple fibroadenomas, breast abscess, pregnancy, liver disease, cervical dysplasia, breast carcinoma, patients desirous of pregnancy in near future

Design outcomes

Primary

Measure	Time frame
To assess reduction in VAS score in mastalgia patients in both groupsTimepoint: Patient s assessment done at baseline, at 4 weeks, at 8 weeks, at 12 weeks and at 24 weeks	—

Secondary

Measure	Time frame
To study the side effects of Ormeloxifene & Vitamin ETimepoint: At baseline, at 4 weeks, at 8 weeks, at 12 weeks & at 24 weeks	—

Countries

India

Contacts

Public ContactDr Prabhu

Aarupadai Veedu Medical College

prabhu.surgeon@gmail.com9787422020

Outcome results

None listed

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