A multi-centre, double-blind, placebo-controlled, multiple-dose crossover proof of concept study to compare the efficacy of mefenamic acid administered vaginally and orally in healthy menstruating women with primary dysmenorrhoea requiring analgesia. - PSD508-DYS-001

• Conditions: Primary dysmenorrhoea requiring analgesia; MedDRA version: 9.1Level: LLTClassification code 10036689Term: Primary dysmenorrhoea

• Registration Number: EUCTR2007-001389-34-GB
• Lead Sponsor: Plethora Solutions Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 105

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: 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified