Drotaverine in Dysmenorrhoea Treatment

• Status: Terminated
• Trial end date: 2006-02-28
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Drotaverin; Ibuprofen; Papaverine

Criteria

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.