A multicenter randomized trial of DIAC for cyclical mastopathy

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Cyclical mastopathy (CM), or fibrocystic disease, commonly causes severe breast pain in up to 70% of women.
• Current treatments may be limited, necessitating novel therapeutic approaches for symptom management.

Purpose of the Study:

• To assess the safety and efficacy of various doses of DIAC compared to a placebo over six months in women diagnosed with CM.
• To establish an optimal dose for DIAC therapy based on a dose-response evaluation.

Main Methods:

• A double-blind, randomized, dose-response, parallel-group clinical trial involving 385 women with moderate to severe cyclical mastalgia.
• Participants received daily oral doses of DIAC or placebo, with assessments including breast examination, pain diaries, and quality-of-life questionnaires over six months.

Main Results:

• The trial enrolled 385 women with CM, with a mean age of 42 years.
• No serious or life-threatening side effects were reported during the study period.
• Data collection was completed, with analysis pending for safety, efficacy, and quality-of-life outcomes.

Conclusions:

• DIAC presents as a promising non-hormonal therapeutic agent for managing cyclical mastopathy.
• Further analysis of the comprehensive trial data will elucidate the full safety and efficacy profile of DIAC for CM treatment.