Condition category
Urological and Genital Diseases
Date applied
15/11/2006
Date assigned
14/12/2006
Last edited
14/09/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Phillip Hay

ORCID ID

Contact details

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

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

http://www.ctscotland.com

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

Publication citations

Additional files

Editorial Notes