Drotaverine in Dysmenorrhoea Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292747
Recruitment Status : Terminated (early termination due to loss of interest and low enrollment of patient)
First Posted : February 16, 2006
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: Drotaverine Drug: Drotaverine Placebo Drug: Ibuprofen Drug: Ibuprofen Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Actual Study Start Date : May 25, 2005
Actual Primary Completion Date : February 28, 2006
Actual Study Completion Date : February 28, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: drotaverine + Ibuprofen placebo
Drotaverine 80 mg plus ibuprofen placebo orally
Drug: Drotaverine
Other Name: Z0124
Drug: Ibuprofen Placebo
Active Comparator: Drotaverine placebo + ibuprofen
Drotaverine placebo plus ibuprofen 400 mg orally
Drug: Drotaverine Placebo Drug: Ibuprofen
Active Comparator: Drotaverine + ibuprofen
Drotaverine 80 mg plus ibuprofen 400 mg orally
Drug: Drotaverine
Other Name: Z0124
Drug: Ibuprofen

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292747

Budapest, Hungary
Sponsors and Collaborators
Study Director: László Erős, MD Sanofi-aventis, Hungary

Responsible Party: Sanofi Identifier: NCT00292747     History of Changes
Other Study ID Numbers: L_9134
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Vasodilator Agents
Phosphodiesterase Inhibitors
Urological Agents