Drotaverine in Dysmenorrhoea Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00292747
• Date of registration: 15/02/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Drotaverine in Dysmenorrhoea Treatment
• Scientific title: Comparison of the Efficacy and Tolerability of Drotaverine 80 mg, Ibuprofen 400 mg and Their Combination in a Calendar Packaging for the Treatment of Primary and Secondary Dysmenorrhoea
• Date of first enrolment: May 25, 2005
• Target sample size: 480
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00292747
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 4

Countries of recruitment

Hungary

Contacts

• Name: László Eros, MD
• Affiliation: Sanofi-aventis, Hungary

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Dysmenorrhea

Intervention(s)

Drug: Drotaverine

Drug: Drotaverine Placebo

Drug: Ibuprofen

Drug: Ibuprofen Placebo

Primary Outcome(s)

Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.

Secondary ID(s)

L_9134

Source(s) of Monetary Support

Please refer to primary and secondary sponsors