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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Primary dysmenorrhoea
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Not provided at time of registration
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20942614 results
You can take part if:
You may not be able to take part if:
1. A history of significant disease deemed by the investigator to render the subject unsuitable for inclusion2. Any significant ongoing painful condition other than that associated with primary dysmenorrhoea3. Any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication4. A history of peptic ulcer, duodenal ulcer, gastrointestinal bleeding5. A history of frequent dyspepsia, heartburn or indigestion6. A history of psychotic illness, attempted suicide, or neurosis7. A positive history of drug or alcohol abuse within the past year8. Those taking any concomitant medications that might confound assessments of pain relief, such as psychotropic drugs, antidepressants, sedative–hypnotics taken within fives times of their elimination half lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) are permitted if the subject has been on a stable dose for at least four weeks prior to Visit 1 (screening) and remain on this dose throughout the study.9. Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).10. A history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any previous history of allergy or known intolerance to any of the drugs or formulation constituents which, in the Investigator's opinion, might preclude use of an non-steroidal anti-inflammatory drug [NSAID], including aspirin sensitive asthma or a previous allergic respresponse to a NSAID, including bronchospasm, urticaria, angioedema and rhinitis)11. Those previously randomised into this study12. Subjects who have received any analgesic, anti-inflammatory, antispasmodic or other therapy for dysmenorrhoea within 6 hours of taking the study medication13. Those who have participated in a clinical trial in the previous 30 days weeks are calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial14. Those suffering with anaemia – (blood test at screening visit)15. Those unable, in the opinion of the investigator, to comply fully with the study requirements
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Prof
Ronald
Eccles
+44 (0)2920 874 102
eccles@cardiff.ac.uk
The study is sponsored by Reckitt Benckiser Healthcare (UK) and funded by Reckitt Benckiser Healthcare (UK).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
