Health Condition 1: null- generally healthy except pain in breast
Conditions
Interventions
Intervention1: Tab Tamoxifen 10 mg
Tab Ormeloxefine 30 mg: Group A: Patients will be treated with tamoxifen 10 mg daily for 12 weeks.
Group B: Patients will be treated with ormeloxefine 30 mg once a w
Sponsors
HLL lifecare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Women with regular menstrual cycle having mastalgia with VAS score greater than or equal to 3 lasting for more than 7 days per cycle
Exclusion criteria
Exclusion criteria: Musculoskeletal or chest wall pain Past history or family history of breast carcinoma Patients with polycystic ovarian diseases and uterine cervical hyperplasia Patients with breast lump or mammary ductal disease First 6 months of lactation Pregnancy Patients who are planning to conceive within the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of ormeloxifine in treating mastalgia as compared to tamoxifen. 2) To identify the optimal dose regimen of ormeloxifine required to bring severity of mastalgia 3 on VASTimepoint: Four Weeks, Eight Weeks, Twelve Weeks and Twenty Four Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety profile and quality of life in patient of mastalgia treated with Tamoxifen and various dosage regimens of Ormeloxefine.Timepoint: Four Weeks, Eight Weeks, Twelve Weeks and Twenty Four Weeks | — |
Countries
India
Contacts
Public ContactDr Anita Dhar
All India Institute of Medical Sciences
Outcome results
None listed