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
Secondary identifying numbers Clin-Gyn-201
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

Courtyard Clinic
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Study information

Study designPhase II double-blind, randomised, placebo-controlled, multi-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesIt 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) studiedBacterial Vaginosis
InterventionDay 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Clindamycin Hydrochloride
Primary outcome measureTherapeutic cure rate of BV
Secondary outcome measures1. Clinical cure rate of BV
2. Improved cure rate of BV
3. Nugent score of BV
4. BV symptom resolution
5. Adverse events
Overall study start date01/04/2007
Completion date30/09/2007
Reason abandoned (if study stopped)No sites were initiated, therefore no patients dosed.

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants177
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2007
Date of final enrolment30/09/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Courtyard Clinic
London
SW17 0QT
United Kingdom

Sponsor information

Controlled Therapeutics (Scotland) Ltd (UK)
Industry

1 Redwood Place
Peel Park Campus
East Kilbride
G74 5PB
United Kingdom

Website http://www.ctscotland.com
ROR logo "ROR" https://ror.org/03e9kb581

Funders

Funder type

Industry

Funded by Controlled Therapeutics (Scotland) Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan