Trial Outcomes & Findings for A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis (NCT NCT01577537)

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

251 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	128	123
Overall Study COMPLETED	120	116
Overall Study NOT COMPLETED	8	7

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=120 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=117 Participants Placebo: Vaginal gel, daily for 7 days	Total n=237 Participants Total of all reporting groups
Age, Continuous	34.9 years STANDARD_DEVIATION 9.9 • n=5 Participants	36.2 years STANDARD_DEVIATION 12.3 • n=7 Participants	35.6 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	117 Participants n=7 Participants	237 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants	81 participants n=7 Participants	164 participants n=5 Participants
Region of Enrollment Belgium	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Germany	27 participants n=5 Participants	26 participants n=7 Participants	53 participants n=5 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=120 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=117 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Clinical Cure at the End of Treatment Visit (EOT)	68 Participants	25 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=120 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=117 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Nugent Cure at the EOT Visit	16 Participants	6 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=120 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=117 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Clinical Cure at the Test of Cure Visit (TOC)	34 Participants	33 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=120 Participants 1% SPL7013 Gel: Vaginal gel, daily for 7 days	HEC Placebo n=117 Participants Placebo: Vaginal gel, daily for 7 days
Number of Women With Nugent Cure at the TOC Visit	16 Participants	13 Participants

SECONDARY outcome

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

Population: Safety population. Two participants of those randomized to the 1% SPL7013 Gel group withdrew consent, did not use study medication, and therefore were not included in the Safety population.

Number of participants experiencing 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=123 Participants Placebo: Vaginal gel, daily for 7 days
Adverse Events Potentially Related to Treatment	17 Participants	9 Participants

Adverse Events

VivaGel

Serious events: 0 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

Adverse event data not reported

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 studies, PIs can publish only after data from all sites are published collectively.
Publication restrictions are in place

Restriction type: OTHER