Contact information
Type
Scientific
Primary contact
Prof Wlodzimierz Baranowski
ORCID ID
Contact details
Department of Gynaecology
Military Institute of the Health Services
Szaserow Str 128
Warsaw
00-909
Poland
+48 (0)22 510 1175
wbaranowski@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSD502-UP-001
Study information
Scientific title
Acronym
Study hypothesis
Hysteroscopy is used extensively in the evaluation of common gynaecological problems such as premenopausal menstrual disorders, infertility and postmenopausal bleeding. It allows direct visualisation of the uterine cavity and the opportunity for targeted biopsy, safe removal of endometrial polyps, and treatment of submucous fibroids, septa and adhesions. There is a general consensus that hysteroscopy is the current gold standard for evaluating intrauterine pathology, including submucous myomas, polyps, hyperplasia and cancer.
This study aims to evaluate the efficacy of PSD502 in relieving discomfort/pain at placement of the tenaculum on the anterior lip of the cervix during outpatient hysteroscopy. Topically delivered agents have a theoretical advantage over cervical injection in terms of ease of administration and the potential for side effects with oral or systemically administered agents.
Ethics approval
Ethics approval received from the local ethics committee (Wojskowy Instytut Medyczny) on the 22nd August 2007 (ref: 121/WIM/2007).
Study design
A phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group, proof of concept study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Discomfort or pain during hysteroscopy
Intervention
Study medication (active or placebo) will be sprayed onto the cervix in 10 metered dose sprays (to give a total of 75 mg lidocaine and 25 mg prilocaine, or placebo). The first spray will be to the cervix, followed by each of the 4 vaginal fornices in clockwise fashion from the anterior fornix (anterior, left lateral, posterior, right lateral); the spraying pattern will be repeated immediately to complete 10 sprays in total. The time of final spray application will be recorded. After a minimum of 5 minutes and no more than 10 minutes, the excess fluid will be swabbed away. A tenaculum will then be used to secure the cervix and the hysteroscope will be inserted. The subject will then undergo the hysteroscopy procedure.
Product: PSD502 is a metered dose spray that delivers a eutectic mixture of lidocaine and prilocaine for topical anaesthesia. Each actuation dispenses 7.5 mg lidocaine and 2.5 mg prilocaine in their base forms. The propellant used in this spray is norflurane (HFA-134a), which also serves as a solvent. The spray provides a concentrated film of local anaesthetic base, which facilitates drug penetration and is capable of providing rapid, superficial anaesthesia of non-keratinised skin.
Dose: Ten metered dose sprays will be used to deliver a total dose of 75 mg lidocaine and 25 mg prilocaine.
Administration: Topical administration to the vagina and cervix approximately 10 minutes, but no sooner than 5 minutes, prior to hysteroscopy.
Intervention type
Drug
Phase
Not Specified
Drug names
Lidocaine, prilocaine
Primary outcome measures
To evaluate the efficacy of PSD502 in relieving discomfort/pain at placement of the tenaculum on the anterior lip of the cervix assessed using a 100 mm VAPS in subjects undergoing hysteroscopy.
Secondary outcome measures
1. To evaluate the efficacy of PSD502 in relieving discomfort/pain during insertion of the hysteroscope as assessed using a VAPS in subjects undergoing hysteroscopy
2. To evaluate the efficacy of PSD502 in relieving discomfort/pain during examination of the uterine cavity as assessed using a VAPS in subjects undergoing hysteroscopy
3. To evaluate the efficacy of PSD502 in relieving the worst discomfort/pain experienced during the entire hysteroscopy procedure using a 4-point discomfort/pain scale
4. To evaluate the need for additional analgesia in the 24 hours after the procedure
5. To evaluate the safety and tolerability of PSD502 administered to the cervix and vagina
Overall trial start date
03/01/2008
Overall trial end date
13/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
A subject will be invited to participate if she meets the following inclusion criteria:
1. Healthy, pre-menopausal female who requires hysteroscopy
2. Aged 18 - 50 years inclusive
3. Clinically insignificant medical history and clinical examination other than the underlying condition requiring treatment, in the opinion of the Investigator
4. Post menstruation, but prior to ovulation at the time of the procedure and has a negative pregnancy test
5. Able to understand and complete the visual analogue pain scale (VAPS) and 4-point discomfort/pain scale, in the opinion of the Investigator
6. Willing and able to provide written informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
24
Participant exclusion criteria
A subject will be excluded from study participation if she meets any of the following criteria:
1. Contraindication to hysteroscopy
2. Known hypersensitivity to amide-type local anaesthetics
3. Received another investigational product within the previous 3 months
4. Current history of alcohol or drug abuse such that the subject is unable to comply with the study procedures or has resulting clinically significant organ damage, in the opinion of the Investigator
5. Clinically-significant medical history or clinical finding (e.g. bleeding diathesis or coagulopathy) that would affect the subject's ability to take part in the study, in the opinion of the Investigator
6. Previous hysteroscopy with technical difficulties or side effects
7. Used lidocaine or prilocaine preparation within 6 hours before the hysteroscopy procedure
Recruitment start date
03/01/2008
Recruitment end date
13/03/2008
Locations
Countries of recruitment
Poland
Trial participating centre
Department of Gynaecology
Warsaw
00-909
Poland
Sponsor information
Organisation
Plethora Solutions Limited (UK)
Sponsor details
4th Floor
233 High Holborn
London
WC1V 7DN
United Kingdom
+44 (0)20 7269 8630
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