A study to find best medicine and its dose for the treatment of breast pain.
Phase 4
- Conditions
- Health Condition 1: null- generally healthy except pain in breast
- Registration Number
- CTRI/2018/02/012043
- Lead Sponsor
- HLL lifecare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effectiveness of ormeloxifine in treating mastalgia as compared to tamoxifen. <br/ ><br>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 Outcome Measures
Name Time Method 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