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
| ISRCTN | ISRCTN06133220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06133220 |
| Protocol serial number | N0106110085 |
| Sponsor | Department of Health (UK) |
| Funder | Gloucestershire Research and Development Consortium (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/04/2015
- 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
Miss Karen Easton
Scientific
Scientific
Advanced Nurse Practitioner-Gynaecology
Russet Ward
Orchard Centre
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open-label placebo study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Dysplasia |
| Intervention | 1. Placebo (saline) 2. Solcogyn |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Solcogyn |
| Primary outcome measure(s) |
Increased number of patients returning to normal cytology after six months of treatment. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 19/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 106 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 19/03/2002 |
| Date of final enrolment | 19/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Gloucestershire Royal Hospital
Gloucester
GL1 3NN
United Kingdom
GL1 3NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
