Condition category
Urological and Genital Diseases
Date applied
22/08/2007
Date assigned
04/10/2007
Last edited
05/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Bell

ORCID ID

Contact details

Bio-Kinetic Europe Limited
14 Great Victoria Street
Belfast
BT2 7BA
Ireland
+ 44 (0)28 9081 8381
david@biokineticeurope.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSD508-DYS-001

Study information

Scientific title

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

Acronym

Study hypothesis

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are commonly prescribed for dysmenorrhoea, and are very effective. However, all oral NSAIDs can cause gastrointestinal upset. This study aims to assess a direct vaginal delivery system for a well established NSAID in patients with primary dysmenorrhoea. Potential advantages for intra-vaginal delivery of NSAIDs are higher local concentrations of active agent and a reduced incidence of gastrointestinal side effects.

Ethics approval

Office for Research Ethics Committees Northern Ireland (ORECNI), 25/05/2007, ref: 07/NIR03/42

Study design

Multi-centre double-blind placebo-controlled multiple-dose crossover study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary dysmenorrhoea

Intervention

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 second menstrual bleed
3. A treatment period visit (Visit 3) prior to the third menstrual bleed
4. A follow-up visit (Visit 4) after treatment of the third menstrual bleed

Dosage:
Oral capsules = 2 x 250 mg
Intra-vaginal NSAID applied to tampons = 1 x 80 mg

Tampons will be used to dose up to six times during a single 24-hour period. Tampons will remain in situ for four hours, except overnight when a tampon may be worn for eight hours if desired. Capsules for oral administration will be taken three times daily (at intervals of eight hours) for 24 hours.

Intervention type

Drug

Phase

Not Applicable

Drug names

Mefenamic acid

Primary outcome measures

To determine the efficacy of intra-vaginal PSD508 on menstrual-related pain, and to compare it with oral NSAID, in normal healthy female subjects with menstrual-related pain during menses. Subjects will record pain intensity on the diary at baseline and a variety of timepoints over 24 hours.

Secondary outcome measures

To evaluate the safety and tolerability of PSD508 in normal healthy female subjects with menstrual-related pain during menses. Variety of variables measuring over a period of 24 hours.

Overall trial start date

03/10/2007

Overall trial end date

29/04/2008

Reason abandoned

Eligibility

Participant 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 to 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Approximately 105 subjects will be enrolled to achieve 90 completed subjects.

Participant 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

Recruitment start date

03/10/2007

Recruitment end date

29/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bio-Kinetic Europe Limited
Belfast
BT2 7BA
Ireland

Sponsor information

Organisation

Plethora Solutions Limited (UK)

Sponsor details

c/o Sheryl Caswell
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
+44 (0)20 7269 8638
sheryl.caswell@plethorasolutions.co.uk

Sponsor type

Industry

Website

http://www.plethorasolutions.co.uk/index.php

Funders

Funder type

Industry

Funder name

Plethora Solutions Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes