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

Starpharma

Status and phase: Completed; Phase 2

Conditions: Recurrent Bacterial Vaginosis (BV)

Treatments: Drug: 1% SPL7013 Gel; Drug: 3% SPL7013 Gel; Drug: placebo gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437722

SPL7013-014

Details and patient eligibility

About

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

Enrollment: 205 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 3 patient groups, including a placebo group

1% SPL7013 Gel

Experimental group

Treatment:

Drug: 1% SPL7013 Gel

3% SPL7013 Gel

Experimental group

Treatment:

Drug: 3% SPL7013 Gel

placebo gel

Placebo Comparator group

Treatment:

Drug: placebo gel