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
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