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

ISRCTN	ISRCTN15152571
DOI	https://doi.org/10.1186/ISRCTN15152571
Protocol serial number	Clin-Gyn-101
Sponsor	Controlled Therapeutics (Scotland) Ltd (UK)
Funder	Controlled Therapeutics (Scotland) Ltd (UK)

Submission date: 17/09/2007
Registration date: 04/10/2007
Last edited: 12/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian Sanderson
Scientific

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

Study information

Primary study design	Interventional
Study design	Phase I single-centre non-randomised non-controlled open study
Secondary study design	Other
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
Study acronym	CHVI
Study objectives	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(s)	Tayside Committee on Medical Research Ethics B, 21/08/2007, ref: 07/S1402/63
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Clindamycin
Primary outcome measure(s)	The concentrations of clindamycin (free base) in plasma at pre-determined time-points.
Key secondary outcome measure(s)	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
Completion date	09/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Female
Target sample size at registration	10
Key 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
Key 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
Date of first enrolment	03/09/2007
Date of final enrolment	09/11/2007

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Drug Development Solutions Limited

Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		12/11/2019	12/11/2019	No	No

Additional files

ISRCTN 15152571_Basic Results_12Nov19.pdf: uploaded 12/11/2019

Editorial Notes

12/11/2019: The basic results of this trial have been uploaded as an additional file.
30/10/2019: No publications found, verifying study status with principal investigator.