Drotaverine in Dysmenorrhoea Treatment

This study has been terminated.
(early termination due to loss of interest and low enrollment of patient)
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 15, 2006
Last updated: November 14, 2008
Last verified: November 2008
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 Intervention Phase
Drug: Drotaverine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by Sanofi:

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

Estimated Enrollment: 480
Study Start Date: May 2005

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292747

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

ClinicalTrials.gov Identifier: NCT00292747     History of Changes
Other Study ID Numbers: L_9134 
Study First Received: February 15, 2006
Last Updated: November 14, 2008
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Signs and Symptoms
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on April 27, 2016