Condition category
Urological and Genital Diseases
Date applied
17/09/2007
Date assigned
04/10/2007
Last edited
08/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Brian Sanderson

ORCID ID

Contact details

Drug Development Solutions Limited
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Clin-Gyn-101

Study information

Scientific title

Acronym

CHVI

Study hypothesis

This study is to confirm the safety, tolerability and the pharmacokinetic profile of the hydrochloride forumation in healthy female volunteers. This treatment is expected to be effective in the treatment of patients diagnosed with bacterial vaginosis.

Hypothesis:
The concentrations of clindamycin (fee base) in plasma at pre-determined time-points.

Please note that as of 18/10/2007 the anticipated end date of this trial was extended from 09/10/2007.

Ethics approval

Tayside Committee on Medical Research Ethics B, 21/08/2007, ref: 07/S1402/63

Study design

Phase I single-centre non-randomised non-controlled open study

Primary study design

Interventional

Secondary study design

Other

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Bacterial vaginosis

Intervention

Pre-trial visit:
Prior to interventions, written informed consent will be gained. A screening assessment and a compliance check will be performed the day before dosing.

Day one:
Pre-dose checks, vitals, menstrual history check, a pre-dose pharmacokinetic (PK) sample and vaginal pH testing will be performed, and a check to see if the volunteer has any signs or symptoms of infection will also be performed.

After this, the study drug (100 mg Clindamycin Hydrochloride Vaginal Insert) will be administered (dosing period = 24 hours). Post insertion checks will include comfort questionnaires, PK blood samples, vitals and vaginal pH. The study drug will be removed at 24 hours and a urine sample for urinalysis will be taken.

Day two:
PK blood samples will be taken.

Days 3, 4, 5 and 6:
PK blood sample, vitals and urine sample for urinalysis information will be taken.

Adverse Events (AEs) and concomitant medication checks will be performed throughout the trial.

Post-trial visit:
Vitals, Electrocardiogram (ECG), safety bloods and urine samples, urine for pregnancy testing and a physical examination will be performed.

Intervention type

Drug

Phase

Phase I

Drug names

Clindamycin

Primary outcome measures

The concentrations of clindamycin (free base) in plasma at pre-determined time-points.

Secondary outcome measures

1. Assessments of all adverse events reported
2. Assessment of tolerability by review of completed comfort questionnaires
3. Assessment of vaginal pH at specified time-points
4. Measurements of residual amounts of clindamycin in used CHVI to calculate the remaining dose of clindamycin in order to determine the amount of drug released from the insert

Overall trial start date

03/09/2007

Overall trial end date

09/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy female volunteers aged between 18 - 50 years
2. Urine negative for a urinary tract infection
3. Up to date with regular pap smear tests in accordance with local health authority guidelines
4. Agree to refrain from placing anything on the following list in their vagina other than the study drug from the day of admission to the clinical trial unit until completion of the follow-up visit:
4.1. Use of feminine deodorant sprays/products, spermicides*, douches, condoms*, tampons, diaphragms* or any other pharmaceutical or over the counter vaginal product
Barrier methods of contraception as indicated above (*) may be resumed following discharge from the clinic (Day 3)
4.2. Vaginal intercourse is permitted except for the 24-hour period prior to admission and during the residential period of the study
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

10

Participant exclusion criteria

1. Volunteers expected to menstruate from Day 0 to Day 6 or during the 48 hours prior to dosing
2. Volunteers who have a vaginal pH of 4.7 or higher and have any other signs or symptoms of infections at screening and prior to Dosing Day 1
3. Volunteers who have any significant history of drug allergies especially to clindamycin or lincomycin
4. Urinary tract infection in the previous 6 months or have a significant history of recurring urinary tract infections
5. Antimicrobial and/or antifungal therapy (systemic or intravaginal) within 14 days of dosing
6. Signs and/or symptoms of vaginal infection or infections within the last month or positive vaginal swab culture (to definite specific pathogens) at screening
7. Known current Sexually Transmitted Infection (STI) to be established by discussion
8. Contraindications for clindamycin per current labelling of marketed intravaginal formulations
9. Diagnosis or treatment in the previous 6 months for Cervical Intra-epithelial Neoplasia (CIN) or cervical carcinoma

Recruitment start date

03/09/2007

Recruitment end date

09/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Drug Development Solutions Limited
Dundee
DD1 9SY
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

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