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

ISRCTN	ISRCTN32847177
DOI	https://doi.org/10.1186/ISRCTN32847177
Secondary identifying numbers	PSD508-DYS-001

Submission date: 22/08/2007
Registration date: 04/10/2007
Last edited: 10/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Bell
Scientific

Bio-Kinetic Europe Limited
14 Great Victoria Street
Belfast
BT2 7BA
Ireland

Phone	+ 44 (0)28 9081 8381
Email	david@biokineticeurope.com

Study information

Study design	Multi-centre double-blind placebo-controlled multiple-dose crossover study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	Office for Research Ethics Committees Northern Ireland (ORECNI), 25/05/2007, ref: 07/NIR03/42
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mefenamic acid
Primary outcome measure	Menstrual-related pain intensity, recorded in a diary at baseline and a variety of timepoints over 24 hours
Secondary outcome measures	Safety and tolerability of PSD508, measured over a period of 24 hours
Overall study start date	03/10/2007
Completion date	29/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Approximately 105 subjects will be enrolled to achieve 90 completed subjects.
Key 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
Key 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
Date of first enrolment	03/10/2007
Date of final enrolment	29/04/2008

Locations

Countries of recruitment

Ireland
United Kingdom

Study participating centre

Bio-Kinetic Europe Limited

Belfast
BT2 7BA
Ireland

Sponsor information

Plethora Solutions Limited (UK)
Industry

c/o Sheryl Caswell
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom

Phone	+44 (0)20 7269 8638
Email	sheryl.caswell@plethorasolutions.co.uk
Website	http://www.plethorasolutions.co.uk/index.php
"ROR"	https://ror.org/02y9vw172

Funders

Funder type

Industry

Plethora Solutions Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

10/07/2017: No publications found, verifying study status with principal investigator.