Drotaverine in Dysmenorrhoea Treatment (NCT00292747) | Clinical Trial Compass
TerminatedPhase 4
Drotaverine in Dysmenorrhoea Treatment
Stopped: early termination due to loss of interest and low enrollment of patient
Hungary480 participantsStarted 2005-05-25
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.