Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

Recurrent Bacterial Vaginosis (BV) Clinical Trial

Official title:

A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437722
• Other study ID #: SPL7013-014
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: October 27, 2013
• Start date: August 2011

Study information

• Verified date: October 2013
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).

• Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria

• Otherwise healthy

Exclusion Criteria:

• No active STIs and/or current UTI

• Previous exposure to SPL7013 Gel

• A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Recurrent Bacterial Vaginosis (BV)
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• 1% SPL7013 Gel
vaginal gel
• 3% SPL7013 Gel
vaginal gel
• placebo gel
vaginal gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Starpharma Pty Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women who have experienced a recurrent episode of BV as a measure of efficacy	Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria	Day 112 +/- 5	No