Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Clin-Gyn-101
Study information
Scientific title
A phase I, single-centre, open study to assess the pharmacokinetic profile and safety of a 100 mg Clindamycin Hydrochloride Vaginal Insert (CHVI) in healthy females
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
See additional file (ISRCTN 15152571_Basic Results_12Nov19)
Publication list
Publication citations
Additional files
- ISRCTN 15152571_Basic Results_12Nov19.pdf uploaded 12/11/2019