Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Post-marketing, Open-label, Observational, Non-interventional, Comparative, Controlled, Monocenter Study of the Efficacy and Safety of Mastodinone in Patients With Fibrocystic Breast Disea
Brief Summary: The aim of this study is to evaluate the effectiveness of the use of the drug, containing Vitex agnus castus extract (VAC), in patients with fibrocystic breast disease . One hundred fifty women over 40 years old were randomized into patient (n=78) and control (n=72) groups. The groups were similar regarding age, nulliparity, menopause and abortion status, family history of breast cancer, alcohol consumption, and smoking. The patient group received two pills containing 200mg of VAC daily for six months, and all participants were evaluated by using a Visual Analogue Scale and ultrasound examination at baseline, 12th and 24th weeks.