Bacterial Vaginosis Urological and Genital Diseases Inflammatory diseases of female pelvic organs
Conditions
Interventions
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 Clinda
Sponsors
Controlled Therapeutics (Scotland) Ltd (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic cure rate of BV | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical cure rate of BV 2. Improved cure rate of BV 3. Nugent score of BV 4. BV symptom resolution 5. Adverse events | — |
Countries
United Kingdom
Outcome results
None listed