Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Clin-Gyn-201
Study information
Scientific title
Acronym
Study hypothesis
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
Thames Valley MREC on the 19/12/2006 (ref: 06/MRE12/84).
Study design
Phase II double-blind, randomised, placebo-controlled, multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Clindamycin Hydrochloride
Primary outcome measures
Therapeutic cure rate of BV
Secondary outcome measures
1. Clinical cure rate of BV
2. Improved cure rate of BV
3. Nugent score of BV
4. BV symptom resolution
5. Adverse events
Overall trial start date
01/04/2007
Overall trial end date
30/09/2007
Reason abandoned
No sites were initiated, therefore no patients dosed.
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
177
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Courtyard Clinic
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
Controlled Therapeutics (Scotland) Ltd (UK)
Sponsor details
1 Redwood Place
Peel Park Campus
East Kilbride
G74 5PB
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Funded by Controlled Therapeutics (Scotland) Ltd (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