A 2 arm randomized control trial to see the role of Centchroman in reducing the size of fibroadenoma

Role of Centchroman in regression of Fibroadenoma: A 2-arm Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055015

Enrollment

104

Registered

2023-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: N62- Hypertrophy of breast

Interventions

Intervention1: Centchroman in regression of size of fibroadenoma: 30 mg Centchroman on alternate days for 3 months Control Intervention1: Placebo in regression of fibroadenoma: Placebo (Tab Calcium) o

Eligibility

Inclusion criteria

Inclusion criteria: Single or multiple Fibroadenoma diagnosed by triple assessment (clinical evaluation, ultrasound scan, and a large-core-needle biopsy) in unilateral or bilateral breasts with largest size of any fibroadenoma not more than 3 cm.

Exclusion criteria

Exclusion criteria: 1. Past history of breast carcinoma or family history of breast carcinoma 2. Patients with polycystic ovarian diseases, cervical hyperplasia, and liver disease or any other co-morbidity 3. Lactation period for first 6 months 4. Pregnancy

Design outcomes

Primary

Measure	Time frame
â?¢Primary outcome: Change in volume of fibroadenoma measured through USG at 12 weeks compared with baseline measurement at first visit.Timepoint: Baseline & at 3 months by USG	—

Secondary

Measure	Time frame
Secondary outcome: Effect on mastalgia in patients of fibroadenoma with mastalgia. Timepoint: At 12 weeks follow up, VAS score	—

Countries

India

Contacts

Public ContactDr Priyanka Rai

Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow

drpriyankarai.rmlims@gmail.com9935692868

Outcome results

None listed

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