Condition category
Signs and Symptoms
Date applied
23/11/2007
Date assigned
13/02/2008
Last edited
13/02/2008
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

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

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