Is drug therapy effective for treatment of benign breast lump?

A Double Blind placebo controlled RCT evaluating efficacy of Ormeloxifene for Fibroadenomas as compared to observation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050286

Enrollment

130

Registered

2023-03-03

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: D249- Benign neoplasm of unspecified breast

Interventions

Intervention1: Ormeloxifene: Tablet Ormeloxifene 30 mg alternate day for three months Control Intervention1: Placebo: Patients will be given tablet of Vitamin B complex on alternate days for three mon

Eligibility

Inclusion criteria

Inclusion criteria: 1. Young women (15 to 40 yrs) with confirmed fibroadenoma on triple assessment 2. Patient willing to give consent

Exclusion criteria

Exclusion criteria: 1. Non-compliant 2. Atypical/complex fibroadenoma 3. Old age women 4. Not giving consent

Design outcomes

Primary

Measure	Time frame
Decrease in the size of Fibroadenoma as assessed by ultrasonographyTimepoint: Baseline, 1-months, 3 months and 6 months	—

Secondary

Measure	Time frame
Ovarian cystTimepoint: Three months and Six months	—

Countries

India

Contacts

Public ContactKratika Agarwal

NSCB Medical College

sky1508@gmail.com

Outcome results

None listed

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