Drotaverine in Dysmenorrhoea Treatment

Study Overview
=================
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.

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

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: Drotaverine
* Drug: Drotaverine Placebo
* Drug: Ibuprofen
* Drug: Ibuprofen Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drotaverine + Ibuprofen placebo<br>Drotaverine 80 mg plus ibuprofen placebo orally | Drug: Drotaverine<br> <br> * Other names: Z0124;Drug: Ibuprofen Placebo<br> <br> |
| Active Comparator: Drotaverine placebo + ibuprofen<br>Drotaverine placebo plus ibuprofen 400 mg orally | Drug: Drotaverine Placebo<br> <br> Drug: Ibuprofen<br> <br> |
| Active Comparator: Drotaverine + ibuprofen<br>Drotaverine 80 mg plus ibuprofen 400 mg orally | Drug: Drotaverine<br> <br> * Other names: Z0124;Drug: Ibuprofen<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  |