Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/04/2015
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

Miss Karen Easton

ORCID ID

Contact details

Advanced Nurse Practitioner-Gynaecology
Russet Ward
Orchard Centre
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0106110085

Study information

Scientific title

A randomised open label placebo study to evaluate the use of Solcogyn applied topically to the cervix in women referred for the assessment of cervical low grade intro-epithelial lesions

Acronym

Study hypothesis

To determine if treatment of a cervical ectopy associated with minor cytological abnormalities but no colposcopic evidence of high grade dysplasia results in a better clearance rate in terms of normal cytology at 6 month follow up than in the placebo controlled group.

Ethics approval

Not provided at time of registration

Study design

Randomised open-label placebo study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Dysplasia

Intervention

1. Placebo (saline)
2. Solcogyn

Intervention type

Drug

Phase

Not Specified

Drug names

Solcogyn

Primary outcome measures

Increased number of patients returning to normal cytology after six months of treatment.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/03/2002

Overall trial end date

19/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

106 women aged 20-50 attending the colposcopy clinic with cytological abnormalities showing borderline or mild changes and who also have a cervical ectopy.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

106

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

19/03/2002

Recruitment end date

19/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gloucestershire Royal Hospital
Gloucester
GL1 3NN
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Gloucestershire Research and Development Consortium (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