Primary dysmenorrhoea Urological and Genital Diseases Dysmenorrhoea
Conditions
Interventions
Subjects will attend a total of four study visits over three menstrual periods:
1. A screening visit (Visit 1) before the first menstrual bleed
2. A treatment period visit (Visit 2) prior to the seco
Sponsors
Plethora Solutions Limited (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy menstruating female with a history of primary dysmenorrhoea 2. Menstrual-related pain with cramping for which she requires the use of analgesics during each cycle 3. Regular menstrual cycles 4. Routinely uses intra-vaginal tampons and is able to use tampons without an applicator 5. Aged 18 to 40 years inclusive 6. No clinically significant medical history and normal clinical examination other than the underlying pathology requiring treatment, in the opinion of the Investigator 7. Able to understand and complete the rating scales 8. Provided written informed consent
Exclusion criteria
Exclusion criteria: A subject will be excluded from study participation if she meets any of the following criteria: 1. Has a history of, or known, hypersensitivity to mefenamic acid 2. Has a history of reactions such as asthma, urticaria, or allergic type reactions to other NSAIDs 3. Has received another investigational product within three months prior to screening 4. Is unwilling to avoid the use of any: 4.1. Opiate* within 24 hours 4.2. NSAID within 6 hours, or 4.3. Paracetamol within 4 hours, of starting study medication 5. Is pregnant, lactating, or is planning to become pregnant during the study 6. Is currently receiving or has received any hormonal contraception within the previous three months 7. Does not agree to use suitable non-hormonal contraception for the duration of the study 8. Has a history of Toxic Shock Syndrome (TSS) 9. Has a current untreated Sexually Transmitted Disease (STD) that could interfere with the study 10. Has, or has had, ulcerative, vesicular or papillomatous lesions of the cervix, vagina or genital area 11. Is known not to respond to mefenamic acid 12. Has signs or symptoms that contraindicate the administration of mefenamic acid 13. Has unresolved alcohol or drug abuse 14. Has severe menorrhagia which, in the opinion of the investigator, could interfere with the study 15. Is using complementary therapy, such as evening primrose oil, for the treatment of symptoms 16. Has any other condition which, in the opinion of the investigator, may interfere with the study *Up to 16 mg codeine per dose (i.e., 2 co-codamol 8/500 mg tablets) is acceptable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual-related pain intensity, recorded in a diary at baseline and a variety of timepoints over 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of PSD508, measured over a period of 24 hours | — |
Countries
United Kingdom
Outcome results
None listed