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Centchroman vs tamoxifen in patients with breast pain

Centchroman Versus Tamoxifen for the Management of Mastalgia: A Randomised Controlled Trial - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059992
Enrollment
68
Registered
2023-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: N644- Mastodynia

Interventions

Intervention1: Centchroman: 30 mg , once daily for 3 months Control Intervention1: Tamoxifen: 10 mg , once daily for 3 months Control Intervention2: Not applicable: Not applicable

Sponsors

Non-funded
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All female patients, aged >18 years 2. Patients, who have complain of mastalgia with or without breast fibroadenoma having persistent symptoms for more than 1 month after reassurance and supportive breast management. 3. Pain severity of >3/10 on visual analog scale.

Exclusion criteria

Exclusion criteria: 1. Acute inflammatory breast conditions (cellulitis , breast abscess) 2. suspicion of malignancy ( clinical or radiological) 3. Family history of breast and ovarian carcinoma 4. Contraindication to centchroman and tamoxifen —-- a.Pregnancy b.Polycystic ovarian diseases ( PCOD ) c.Cervical hyperplasia do d.Recent history or clinical evidence of jaundice or liver diseases e Conditions like, chronic illness such as tuberculosis, renal diseases, severe allergic states etc. f.Patients willing to conceive within six months. 5.History of chest trauma 6.Severe drug reaction to either centchroman or tamoxifen after starting treatment

Design outcomes

Primary

MeasureTime frame
The comparison of pain score in the mastalgia patients with or without fibroadenoma undergoing treatment with centchroman and tamoxifen with Visual analog scale at end of 3 month treatment. Timepoint: Visual analog scale at end of 3 month treatment.

Secondary

MeasureTime frame
To compare the response in size of fibroadenoma To compare patient satisfaction with likert scale Timepoint: Visual analog scale at end of 3 month treatment.

Countries

India

Contacts

Public ContactRishik Dhawan

AIIMS JODHPUR

drsatyaprakash04@gmail.com8010861072

Outcome results

None listed

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