Bacterial vaginosis Urological and Genital Diseases Acute vaginitis
Conditions
Interventions
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.
Sponsors
Controlled Therapeutics (Scotland) Ltd (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentrations of clindamycin (free base) in plasma at pre-determined time-points. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed