A phase II, double-blind, randomised, placebo-controlled, multi-centre trial to assess the efficacy and safety of the 100 mg clindamycin hydrochloride vaginal insert in women diagnosed with bacterial vaginosis
| ISRCTN | ISRCTN33336878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33336878 |
| Protocol serial number | Clin-Gyn-201 |
| Sponsor | Controlled Therapeutics (Scotland) Ltd (UK) |
| Funder | Funded by Controlled Therapeutics (Scotland) Ltd (UK) |
- Submission date
- 15/11/2006
- Registration date
- 14/12/2006
- Last edited
- 14/09/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Dr Phillip Hay
Scientific
Scientific
Courtyard Clinic
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II double-blind, randomised, placebo-controlled, multi-centre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | It is anticipated that the Clindamycin Hydrochloride Vaginal Insert (CHVI) will provide therapeutic levels of clindamycin to the affected tissues over a sustained period. Please note that this trial was cancelled (no sites were initiated, therefore no patients were dosed). |
| Ethics approval(s) | Thames Valley MREC on the 19/12/2006 (ref: 06/MRE12/84). |
| Health condition(s) or problem(s) studied | Bacterial Vaginosis |
| Intervention | Day zero: screening assessment - 1. Written informed consent 2. Vaginal examination 3. Collect specimens for the diagnosis of BV 4. Diary card given to all subjects to complete Method: 100 mg Clindamycin Hydrochloride Vaginal Insert to be self administered at home (dosing period approximately 24 hours) Day eight: follow-up telephone call - 1. Subjects questioned regarding BV symptoms and any Adverse Events (AE) 2. Subjects will be instructed to contact the clinic at any time if they have any AE of concern or BV symptoms. The Investigator will decide if the subject should return to the clinic for assessment and treatment. Day 26: follow-up visit - 1. Vaginal examination 2. Collect specimens for BV |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Clindamycin Hydrochloride |
| Primary outcome measure(s) |
Therapeutic cure rate of BV |
| Key secondary outcome measure(s) |
1. Clinical cure rate of BV |
| Completion date | 30/09/2007 |
| Reason abandoned (if study stopped) | No sites were initiated, therefore no patients dosed. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 177 |
| Key inclusion criteria | 1. Clinical diagnosis of Bacterial Vaginosis (BV), defined as having all four Amsel criteria 2. Gram stain slide Nugent score greater than or equal to four 3. No evidence of genital warts on vaginal and perineal examination 4. Provide written informed consent |
| Key exclusion criteria | 1. Known hypersensitivity to clindamycin or lincomycin 2. Diagnosis and received treatment for BV in the previous three months 3. Urinary tract infection in the previous six months 4. Diagnosis or treatment in the previous six months for Cervical Intra-epithelial Neoplasia (CIN) or cervical carcinoma 5. Unavailable for the follow-up visit |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Courtyard Clinic
London
SW17 0QT
United Kingdom
SW17 0QT
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 |
