Primary dysmenorrhoea requiring analgesia MedDRA version: 9.1 Level: LLT Classification code 10036689 Term: Primary dysmenorrhoea
Conditions
Interventions
Product Name: PSD508
Product Code: PSD508
Pharmaceutical Form: Vaginal delivery system
INN or Proposed INN: mefenamic acid
CAS Number: 61-68-7
Current Sponsor code: PSD508
Concentration unit: mg milli
Sponsors
Plethora Solutions Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population will be normal healthy menstruating female volunteers. Subjects will have a self reported history of primary dysmenorrhoea that includes menstrual related pain with cramping for which they require analgesics. Inclusion Criteria: A subject will be invited to participate if she meets the following inclusion criteria: 1. Is a healthy menstruating female with a history of primary dysmenorrhoea. 2. Has menstrual-related pain with cramping for which she requires the use of analgesics during each cycle. 3. Has regular menstrual cycles. 4. Routinely uses intra-vaginal tampons and is able to use tampons without an applicator. 5. Is aged 18 – 40 years inclusive. 6. Has no clinically significant medical history and normal clinical examination other than the underlying pathology requiring treatment, in the opinion of the Investigator. 7. Is able to understand and complete the rating scales. 8. Has provided written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 non-steroidal anti-inflammatory drugs (NSAIDs). 3. Has received another investigational product within 3 months prior to screening. 4. Is unwilling to avoid the use of any 1) opiate within 24 hours, 2) NSAID within 6 hours, or 3) paracetamol within 4 hours, of starting study medication. [Up to 16 mg codeine per dose (i.e., 2 co-codamol 8/500 mg tablets) is allowed] 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 3 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the efficacy of intra-vaginal mefenamic acid 80 mg (PSD508) on menstrual-related pain, and to compare it with oral mefenamic acid 500 mg, in normal healthy female subjects with menstrual-related pain during menses.;Secondary Objective: To evaluate the safety and tolerability of PSD508 in normal healthy female subjects with menstrual-related pain during menses.;Primary end point(s): Efficacy: The primary efficacy variable is the Summed Pain Intensity Difference over 8 hours (SPID-8) after the first treatment. The Pain Intensity Difference (PID) at each post-treatment time-point is calculated as the pain intensity at that time-point minus the pain intensity at baseline. SPID-8 is then the weighted sum of PID over the 8 hours after the first tampon. Secondary efficacy variables include the Total Pain Relief over the 8 hours following the first tampon (TOTPAR-8), global assessment of efficacy, degree of interference with daily activities, drug preference rating, and rescue medication usage. Safety: AEs, serious adverse events (SAEs), vital signs and physical examination will be recorded. Pharmacokinetics: None | — |
Countries
United Kingdom
Outcome results
None listed