Drotaverine in Dysmenorrhoea Treatment

Phase 4

Terminated

• Conditions: Dysmenorrhea
• Interventions: Drug: Drotaverine Placebo; Drug: Drotaverine; Drug: Ibuprofen Placebo; Drug: Ibuprofen

• Registration Number: NCT00292747
• Lead Sponsor: Sanofi

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 the treatment of primary and secondary dysmenorrhoea.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-25
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-16
• Primary Completion: 2006-02-28
• Study Completion: 2006-02-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drotaverine + Ibuprofen placebo	Ibuprofen Placebo	Drotaverine 80 mg plus ibuprofen placebo orally
Drotaverine placebo + ibuprofen	Drotaverine Placebo	Drotaverine placebo plus ibuprofen 400 mg orally
drotaverine + Ibuprofen placebo	Drotaverine	Drotaverine 80 mg plus ibuprofen placebo orally
Drotaverine placebo + ibuprofen	Ibuprofen	Drotaverine placebo plus ibuprofen 400 mg orally
Drotaverine + ibuprofen	Drotaverine	Drotaverine 80 mg plus ibuprofen 400 mg orally
Drotaverine + ibuprofen	Ibuprofen	Drotaverine 80 mg plus ibuprofen 400 mg orally

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇭🇺 Budapest, Hungary