Phase 3
N=586
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT02237950 ↗Enrolled (actual)
586
Serious AEs
1.2%
Results posted
Jul 2019
Primary outcome: Primary: Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings — 130; 158 Participants — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metronidazole oral tablets 500mg (Drug); 1% SPL7013 Gel (Drug); Placebo gel (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Starpharma Pty Ltd
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings |
194; 213 | 0.059 |
| SECONDARY Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings |
105; 99 | 0.007 sig |
| SECONDARY Recurrence of Patient-reported BV Symptoms |
75; 108 | 0.002 sig |
| SECONDARY Recurrence of Individual Amsel Criteria |
104; 132 | 0.014 sig |
| SECONDARY Recurrence of BV as Determined by Presence of a Nugent Score of 7-10 |
95; 135 | 0.012 sig |
| SECONDARY Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings |
194; 213 | 0.059 |
| SECONDARY Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10. |
81; 111 | 0.008 sig |
| SECONDARY Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score |
1.6; 0.1 | — |
| SECONDARY Adverse Events (AEs) |
37; 33 | — |
Summary
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
Eligibility Criteria
Inclusion Criteria
- Current active episode of BV (diagnosis defined as: At least 3 of the 4 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
- History of recurrent BV (at least 3 episodes in previous year including current episode)
- Using an effective method of contraception
Exclusion Criteria
- Test positive for a sexually transmitted infection
- Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
- Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02237950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.