Efficacy and safety of aceclofenac and drotaverine fixed-dose combination in the treatment of primary dysmenorrhoea: a double-blind, double-dummy, randomized comparative study with aceclofenac.

Objective: To evaluate the efficacy and safety of aceclofenac-drotaverine combination against aceclofenac alone in patients with primary dysmenorrhoea.

Study Design: This double-blind, double-dummy, randomized, comparative, multicentric study enrolled 200 women (100 women in each arm) in the age range of 18-35 years with primary dysmenorrhoea at four centers. The patients were randomly allocated to either aceclofenac 100mg-drotaverine 80 mg b.