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

NCT ID: NCT01437722

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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

Detailed Description

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Conditions

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Recurrent Bacterial Vaginosis (BV)

Keywords

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BV Bacterial vaginosis recurrent SPL7013 Gel VivaGel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1% SPL7013 Gel

Group Type EXPERIMENTAL

1% SPL7013 Gel

Intervention Type DRUG

vaginal gel

3% SPL7013 Gel

Group Type EXPERIMENTAL

3% SPL7013 Gel

Intervention Type DRUG

vaginal gel

placebo gel

Group Type PLACEBO_COMPARATOR

placebo gel

Intervention Type DRUG

vaginal gel

Interventions

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1% SPL7013 Gel

vaginal gel

Intervention Type DRUG

3% SPL7013 Gel

vaginal gel

Intervention Type DRUG

placebo gel

vaginal gel

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Starpharma Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy Paull, PhD

Role: STUDY_DIRECTOR

Starpharma Pty Ltd

Countries

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United States

Other Identifiers

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SPL7013-014

Identifier Type: -

Identifier Source: org_study_id