Status:
TERMINATED
Drotaverine in Dysmenorrhoea Treatment
Lead Sponsor:
Sanofi
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2005
Trial Type :
INTERVENTIONAL
End Date :
February 28 2006
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00292747
Start Date
May 25 2005
End Date
February 28 2006
Last Update
August 8 2017
Active Locations (1)
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1
Sanofi-Aventis
Budapest, Hungary