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Drotaverine in Dysmenorrhoea Treatment

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Sanofi

Status and phase

Terminated
Phase 4

Conditions

Dysmenorrhea

Treatments

Drug: Ibuprofen
Drug: Ibuprofen Placebo
Drug: Drotaverine
Drug: Drotaverine Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

480 participants in 3 patient groups

drotaverine + Ibuprofen placebo
Experimental group
Description:
Drotaverine 80 mg plus ibuprofen placebo orally
Treatment:
Drug: Ibuprofen Placebo
Drug: Drotaverine
Drotaverine placebo + ibuprofen
Active Comparator group
Description:
Drotaverine placebo plus ibuprofen 400 mg orally
Treatment:
Drug: Drotaverine Placebo
Drug: Ibuprofen
Drotaverine + ibuprofen
Active Comparator group
Description:
Drotaverine 80 mg plus ibuprofen 400 mg orally
Treatment:
Drug: Ibuprofen
Drug: Drotaverine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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