Oral versus Gel formulation of drug Tamoxifen in Cyclical Breast pain

Oral Versus Topical Tamoxifen In Cyclical Mastalgia - A Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015845

Enrollment

150

Registered

2018-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E349- Endocrine disorder, unspecified

Interventions

Intervention1: TAMOXIFEN: All women with cyclical mastalgia satisfying the inclusion criteria will be divided into Group 1 and Group 2 . Group 1 will get Tamoxifen tablet 20 mg once a day after food e

Eligibility

Inclusion criteria

Inclusion criteria: Pre-menopausal women of or above 18 yrs of age having cyclical mastalgia for a period of 4 months or more who have completed their families

Exclusion criteria

Exclusion criteria: Adult women having pain in the breast due to a diagnosed and medically predetermined cause for example ca breast and extramammary pain costochondritis

Design outcomes

Primary

Measure	Time frame
In all patients with cyclical mastalgia , assessment of reduction in breast pain on using Tamoxifen tablet versus Tamoxifen gel preparationTimepoint: 3 months	—

Secondary

Measure	Time frame
In all patients with cyclical mastalgia to assess the reduction in nodularity , compliance on using tablet tamoxifen versus gel tamoxifenTimepoint: assessment at 3 months and then follow up upto 6 months	—

Countries

India

Contacts

Public ContactDIVYA DHANANJAY SINGH

JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH

kadambari1909@gmail.com9843323420

Outcome results

None listed

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