Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

Starpharma

Status and phase: Completed; Phase 2

Conditions: Bacterial Vaginosis

Treatments: Drug: 0.5% SPL7013 Gel; Drug: 1.0% SPL7013 Gel; Other: Placebo Gel; Drug: 3.0% SPL7013 Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01201057

SPL7013-013

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.

Enrollment: 132 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
• Otherwise healthy

Exclusion criteria

• No active STIs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups, including a placebo group

0.5% SPL7013 Gel

Experimental group

Treatment:

Drug: 0.5% SPL7013 Gel

1.0% SPL7013 Gel

Experimental group

Treatment:

Drug: 1.0% SPL7013 Gel

3.0% SPL7013 Gel

Experimental group

Treatment:

Drug: 3.0% SPL7013 Gel

Placebo Gel

Placebo Comparator group

Treatment:

Other: Placebo Gel