Drotaverine in Dysmenorrhoea Treatment

Comparison of the Efficacy and Tolerability of Drotaverine 80 mg, Ibuprofen 400 mg and Their Combination in a Calendar Packaging for the Treatment of Primary and Secondary Dysmenorrhoea

The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.

Inclusion Criteria:

• History of at least 6 months of dysmenorrhea, with presence of moderate to severe pain in each of the last 3 cycles
• With regular menstrual cycles (25-35 days)
• Using an adequate barrier contraception method (except for virgins)

Exclusion Criteria:

• Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
• Proven hypersensitivity to drotaverine hydrochloride or ibuprofen or proven intolerance to lactose
• Any described contraindication to either drotaverine hydrochloride or ibuprofen (see Summary of Product Characteristics)
• Oestro-progestative contraception within the last 2 months
• Regular use of sedative, hypnotics, tranquillizers or any other addictive agents
• History or evidence of acute or chronic alcohol abuse
• Heavy smoking (> 10 cigarettes/day)
• Need of a permanent treatment with other antispasmodics and/or analgesic agents during the trial
• Lactation
• Pregnancy
• Participation in another clinical trial in the last 3 months prior to the start of this study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.