Drotaverine in Dysmenorrhoea Treatment

Dysmenorrhea Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00292747
• Other study ID #: L_9134
• Status: Terminated
• Phase: Phase 4
• First received: February 15, 2006
• Last updated: August 4, 2017
• Start date: May 25, 2005
• Est. completion date: February 28, 2006

Study information

• Verified date: August 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 480
• Est. completion date: February 28, 2006
• Est. primary completion date: February 28, 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Drotaverine

• Drotaverine Placebo

• Ibuprofen

• Ibuprofen Placebo

Locations

Country	Name	City	State
Hungary	Sanofi-Aventis	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.