A phase II, double-blind, randomised, placebo-controlled, multi-centre trial to assess the efficacy and safety of the 100 mg clindamycin hydrochloride vaginal insert in women diagnosed with bacterial vaginosis

Completed

• Conditions: Bacterial Vaginosis; Urological and Genital Diseases; Inflammatory diseases of female pelvic organs

• Registration Number: ISRCTN33336878
• Lead Sponsor: Controlled Therapeutics (Scotland) Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 177

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic cure rate of BV

Secondary Outcome Measures

Name	Time	Method
1. Clinical cure rate of BV<br>2. Improved cure rate of BV<br>3. Nugent score of BV<br>4. BV symptom resolution<br>5. Adverse events