NCT02237950

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Completed Phase 3 Results posted Last updated 22 July 2019

What this trial tests

Phase 3 trial testing Metronidazole oral tablets 500mg in Bacterial Vaginosis in 586 participants. Completed in 22 February 2017.

Timeline

13 October 2014

Primary endpoint
9 December 2016

22 February 2017

Quick facts

Lead sponsor	Starpharma Pty Ltd
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	586
Start date	13 October 2014
Primary completion	9 December 2016
Estimated completion	22 February 2017
Sites	45 locations across Canada, United States, Puerto Rico

Drugs / interventions tested

• Metronidazole oral tablets 500mg — full drug profile →
• 1% SPL7013 Gel — full drug profile →
• Placebo gel

Conditions studied

• Bacterial Vaginosis — all drugs for Bacterial Vaginosis →

Sponsor

Starpharma Pty Ltd — full company profile →

Who can join

Adults 16 to 45, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings Primary · At or by the Week 16 visit

Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)

Group	Value	95% CI
1% SPL7013 Gel	130
Placebo Gel	158

Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings Secondary · At or by the Week 16 visit

Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)

Group	Value	95% CI
1% SPL7013 Gel	105	98 – 111
Placebo Gel	99	87 – 106

Recurrence of Patient-reported BV Symptoms Secondary · At or by the Week 16 visit

Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)

Group	Value	95% CI
1% SPL7013 Gel	75
Placebo Gel	108

Recurrence of Individual Amsel Criteria Secondary · At or by the Week 16 visit

Number of participants with positive individual Amsel criterion \- Clue cells representing at least 20% of total epithelial cells

Group	Value	95% CI
1% SPL7013 Gel	104
Placebo Gel	132

Recurrence of BV as Determined by Presence of a Nugent Score of 7-10 Secondary · At or by the Week 16 visit

Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.

Group	Value	95% CI
1% SPL7013 Gel	95
Placebo Gel	135

Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings Secondary · At or by the Week 24 visit

Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)

Group	Value	95% CI
1% SPL7013 Gel	194
Placebo Gel	213

Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10. Secondary · At or by the Week 16 visit

Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.

Group	Value	95% CI
1% SPL7013 Gel	81
Placebo Gel	111

Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score Secondary · Baseline to Week 16

Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functionin

Group	Value	95% CI
1% SPL7013 Gel	1.6	-0.5 – 3.7
Placebo Gel	0.1	-2.0 – 2.1

Adverse Events (AEs) Secondary · From Baseline to end of Week 28

Number of participants with genitourinary AEs considered potentially related to study treatment

Group	Value	95% CI
1% SPL7013 Gel	37
Placebo Gel	33

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

1% SPL7013 Gel

Serious: 4/294 (1%)

Deaths: —

Placebo Gel

Serious: 3/291 (1%)

Deaths: —

Serious adverse events (7 terms)

Reaction	System	1% SPL7013 Gel	Placebo Gel
Tachycardia	Cardiac disorders	—	—
Bartholin's abscess	Infections and infestations	—	—
Klebsiella bacteremia	Infections and infestations	—	—
Hemiplegic migraine	Nervous system disorders	—	—
Blighted ovum	Pregnancy, puerperium and perinatal conditions	—	—
Suicidal ideation	Psychiatric disorders	—	—
Menorrhagia	Reproductive system and breast disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	1% SPL7013 Gel	Placebo Gel
Vulvovaginal candidiasis	Infections and infestations	—	—
UTI	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Vulvovaginal mycotic infection	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—

Most-reported serious reactions: Tachycardia, Bartholin's abscess, Klebsiella bacteremia, Hemiplegic migraine, Blighted ovum, Suicidal ideation, Menorrhagia.

Data from ClinicalTrials.gov NCT02237950 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dendrimers, an Emerging Opportunity in Personalized Medicine?
   Caminade AM. · · 2022 · cited 39× · PMID 36013283 · DOI 10.3390/jpm12081334
2. Dendrimer-Mediated Delivery of DNA and RNA Vaccines.
   Kisakova LA, Apartsin EK, Nizolenko LF, Karpenko LI. · · 2023 · cited 29× · PMID 37111593 · DOI 10.3390/pharmaceutics15041106
3. A phase 3, randomized, controlled trial of Astodrimer 1% Gel for preventing recurrent bacterial vaginosis.
   Schwebke JR, Carter BA, Waldbaum AS, Agnew KJ, et al · · 2021 · cited 15× · PMID 33537666 · DOI 10.1016/j.eurox.2021.100121