Trial Outcomes & Findings for A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis (NCT NCT01577238)

Results Overview

Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

250 participants

Primary outcome timeframe

Day 9-12

Results posted on

2019-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	VivaGel 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo Placebo: Vaginal gel, daily for 7 days
Overall Study STARTED	127	123
Overall Study COMPLETED	117	111
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VivaGel n=117 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=115 Participants Placebo: Vaginal gel, daily for 7 days	Total n=232 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 10.0 • n=99 Participants	32.9 years STANDARD_DEVIATION 9.7 • n=107 Participants	32.6 years STANDARD_DEVIATION 9.8 • n=206 Participants
Sex: Female, Male Female	117 Participants n=99 Participants	115 Participants n=107 Participants	232 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	117 participants n=99 Participants	115 participants n=107 Participants	232 participants n=206 Participants

PRIMARY outcome

Timeframe: Day 9-12

Population: mITT

Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

Outcome measures

Outcome measures
Measure	VivaGel n=117 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=115 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Clinical Cure at the End of Treatment Visit (EOT)	59 Participants	19 Participants

SECONDARY outcome

Timeframe: Day 9-12

Population: mITT

Nugent Cure is defined as a Nugent score of 0-3 (normal)

Outcome measures

Outcome measures
Measure	VivaGel n=117 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=115 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Nugent Cure at the EOT Visit	15 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 21-30

Population: mITT

Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

Outcome measures

Outcome measures
Measure	VivaGel n=117 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=115 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Clinical Cure at the Test of Cure Visit (TOC)	31 Participants	24 Participants

SECONDARY outcome

Timeframe: Day 21-30

Population: mITT

Nugent Cure is defined as a Nugent score of 0-3 (normal)

Outcome measures

Outcome measures
Measure	VivaGel n=117 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=115 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Nugent Cure at the TOC Visit	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Screening/baseline through TOC visit, Day 1-30

Population: Safety population. One participant of those randomized to the 1% SPL7013 Gel was lost to follow-up, and two participants of those randomized to Placebo did not use study medication, and therefore were not included in the Safety population.

Number of participants with adverse events considered potentially related to study treatment

Outcome measures

Outcome measures
Measure	VivaGel n=126 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=121 Participants Placebo: Vaginal gel, daily for 7 days
Adverse Events Potentially Related to Treatment	20 Participants	14 Participants

Adverse Events

VivaGel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

HEC Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VivaGel n=126 participants at risk 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=121 participants at risk Placebo: Vaginal gel, daily for 7 days
Infections and infestations Pneumonia	0.79% 1/126 Analysis of all participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused (Safety population). This population is broader than the modified intent-to-treat population, which included all participants in the Safety population who had a Nugent score of 4-10 at Baseline, but excluded those with a Nugent score of 0-3.	0.00% 0/121 Analysis of all participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused (Safety population). This population is broader than the modified intent-to-treat population, which included all participants in the Safety population who had a Nugent score of 4-10 at Baseline, but excluded those with a Nugent score of 0-3.

Other adverse events

Adverse event data not reported

Additional Information

Dr Jeremy Paull

Starpharma

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For multicenter trials, PIs can publish only after the data from all sites are published collectively.
Publication restrictions are in place

Restriction type: OTHER