Drotaverine in Dysmenorrhoea Treatment

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00292747

Enrollment

480

Registered

2006-02-16

Start date

2005-05-25

Completion date

2006-02-28

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

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.

Interventions

DRUGDrotaverine

DRUGDrotaverine Placebo

DRUGIbuprofen

DRUGIbuprofen Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

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

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026