A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Starpharma

Status and phase: Completed; Phase 3

Conditions: Bacterial Vaginosis

Treatments: Drug: 1% SPL7013 Gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01577537

SPL7013-016

Details and patient eligibility

About

The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

Enrollment: 251 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key eligibility criteria:

• Post-menarchal females, aged 12 years or more
• Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
• Nugent score of at least 4
• Otherwise healthy, as determined by medical history, physical examination
• normal Pap smear at or documented within 24 months of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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251 participants in 2 patient groups, including a placebo group

VivaGel

Experimental group

Treatment:

Drug: 1% SPL7013 Gel

HEC Placebo

Placebo Comparator group

Treatment:

Drug: Placebo