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

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

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Key information

Conditions

Recurrent Bacterial Vaginosis (BV) Bacterial Infections Bacterial Infections and Mycoses Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1% SPL7013 Gel

Drug

vaginal gel

3% SPL7013 Gel

Drug

vaginal gel

Placebo Gel

Drug

vaginal gel

Primary outcomes

Number of women who have experienced a recurrent episode of BV as a measure of efficacy

Time frame: Day 112 +/- 5

Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria

Sponsors and collaborators

Lead sponsor

Starpharma Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2012
First posted: Sep 21, 2011
Registry last updated: Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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