TerminatedPhase 4

Drotaverine in Dysmenorrhoea Treatment

Stopped: early termination due to loss of interest and low enrollment of patient

Hungary480 participantsStarted 2005-05-25

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00292747

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-02-28

View on ClinicalTrials.gov More Dysmenorrhea trials