Drotaverine in Dysmenorrhoea Treatment
Dysmenorrhea
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
drotaverine + Ibuprofen placebo
Drotaverine placebo + ibuprofen
Drotaverine + ibuprofen
Drotaverine 80 mg plus ibuprofen placebo orally
Drotaverine placebo plus ibuprofen 400 mg orally
Drotaverine 80 mg plus ibuprofen 400 mg orally