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Drotaverine in Dysmenorrhoea Treatment

TerminatedPhase 4

Sponsor: Sanofi

Conditions: Dysmenorrhea

Interventions: Drotaverine, Drotaverine Placebo, Ibuprofen, Ibuprofen Placebo

Countries: Hungary

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Budapest, Hungary