Trial Outcomes & Findings for Multi-Center Study of New Medications to Treat Vaginal Infections (NCT NCT02308007)

NCT ID: NCT02308007

Last Updated: 2020-08-04

Results Overview

The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is \<20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 475 participants
• Primary outcome timeframe: 7-14 days after beginning treatment
• Results posted on: 2020-08-04

Participant Flow

Participant milestones

Measure	Terconazole Vaginal Gel One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel One applicator full at bedtime Terconazole/metronidazole
Overall Study STARTED	159	159	157
Overall Study COMPLETED	83	84	82
Overall Study NOT COMPLETED	76	75	75

Reasons for withdrawal

Measure	Terconazole Vaginal Gel One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel One applicator full at bedtime Terconazole/metronidazole
Overall Study Normal Gram stain or neg yeast culture	66	64	67
Overall Study Positive for STD at Baseline	7	11	7
Overall Study Lost to Follow-up	3	0	1

Baseline Characteristics

Multi-Center Study of New Medications to Treat Vaginal Infections

Baseline characteristics by cohort

Measure	Terconazole Vaginal Gel n=83 Participants One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=84 Participants One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=82 Participants One applicator full at bedtime Terconazole/metronidazole	Total n=249 Participants Total of all reporting groups
Age, Continuous	31.5 years STANDARD_DEVIATION 9.17 • n=93 Participants	31.0 years STANDARD_DEVIATION 9.43 • n=4 Participants	32.6 years STANDARD_DEVIATION 10.57 • n=27 Participants	31.7 years STANDARD_DEVIATION 9.72 • n=483 Participants
Sex: Female, Male Female	83 Participants n=93 Participants	84 Participants n=4 Participants	82 Participants n=27 Participants	249 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=93 Participants	15 Participants n=4 Participants	9 Participants n=27 Participants	39 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=93 Participants	69 Participants n=4 Participants	73 Participants n=27 Participants	210 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Black or African American	52 Participants n=93 Participants	54 Participants n=4 Participants	50 Participants n=27 Participants	156 Participants n=483 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants	26 Participants n=4 Participants	28 Participants n=27 Participants	84 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	83 participants n=93 Participants	84 participants n=4 Participants	82 participants n=27 Participants	249 participants n=483 Participants

PRIMARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication)

The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is <20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis

Outcome measures

Measure	Terconazole Vaginal Gel n=83 Participants One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=84 Participants One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=82 Participants One applicator full at bedtime Terconazole/metronidazole
Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit	31 Participants	29 Participants	43 Participants

SECONDARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication)

The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was defined as: 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is <20% clue cells

Outcome measures

Measure	Terconazole Vaginal Gel n=83 Participants One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=84 Participants One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=82 Participants One applicator full at bedtime Terconazole/metronidazole
Cure of the BV Component of Mixed Infection	38 Participants	46 Participants	54 Participants

SECONDARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication)

The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC

Outcome measures

Measure	Terconazole Vaginal Gel n=83 Participants One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=84 Participants One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=82 Participants One applicator full at bedtime Terconazole/metronidazole
Cure of the VVC Component of Mixed Infection	52 Participants	37 Participants	53 Participants

SECONDARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication)

The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture.

Outcome measures

Measure	Terconazole Vaginal Gel n=83 Participants One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=84 Participants One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=82 Participants One applicator full at bedtime Terconazole/metronidazole
Microbiologic and Mycologic Cure	19 Participants	5 Participants	24 Participants

SECONDARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (Baseline Nugent Gram stain score of 4 or more, and positive baseline yeast culture, and used at least one dose of study medication)

Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.

Outcome measures

Measure	Terconazole Vaginal Gel n=83 Participants One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=84 Participants One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=82 Participants One applicator full at bedtime Terconazole/metronidazole
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit	49 Participants	44 Participants	49 Participants

SECONDARY outcome

Timeframe: Any time during study participation (up to 30 days)

Population: Safety population, defined as all subjects randomized to treatment and administered at least one dose of study drug

Adverse events were collected at study visits, from subject diaries and from spontaneous reports

Outcome measures

Measure	Terconazole Vaginal Gel n=149 Participants One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=151 Participants One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=154 Participants One applicator full at bedtime Terconazole/metronidazole
Number of Participants With Treatment Emergent Adverse Events	44 Participants	40 Participants	44 Participants

Adverse Events

Terconazole Vaginal Gel

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Metronidazole Vaginal Gel

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Terconazole/Metronidazole Vaginal Gel

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Terconazole Vaginal Gel n=149 participants at risk One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=151 participants at risk One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=154 participants at risk One applicator full at bedtime Terconazole/metronidazole
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.67% 1/149 • Number of events 1 • The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a negative yeast culture and/or normal gram stain at the baseline visit. Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment). Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting.	0.00% 0/151 • The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a negative yeast culture and/or normal gram stain at the baseline visit. Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment). Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting.	0.00% 0/154 • The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a negative yeast culture and/or normal gram stain at the baseline visit. Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment). Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting.

Other adverse events

Measure	Terconazole Vaginal Gel n=149 participants at risk One applicator full at bedtime Terconazole	Metronidazole Vaginal Gel n=151 participants at risk One applicator full at bedtime Metronidazole	Terconazole/Metronidazole Vaginal Gel n=154 participants at risk One applicator full at bedtime Terconazole/metronidazole
Reproductive system and breast disorders Vulvovaginal burning sensation	3.4% 5/149 • Number of events 5 • The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a negative yeast culture and/or normal gram stain at the baseline visit. Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment). Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting.	4.0% 6/151 • Number of events 6 • The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a negative yeast culture and/or normal gram stain at the baseline visit. Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment). Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting.	5.2% 8/154 • Number of events 8 • The safety population includes all participants randomized to treatment and administered at least one dose of study drug, and includes subjects who had a negative yeast culture and/or normal gram stain at the baseline visit. Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment). Adverse events were collected through direct questioning at each post-baseline visit, by participant diaries, and by spontaneous reporting.

Additional Information

Vice President

Curatek Pharmaceuticals

Phone: 847-806-7680

Email: info@curatek.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigators have the right to disclose and publish results of the Study conducted by them; provided that, in order to protect any Curatek confidential information, Investigator shall submit to Curatek manuscripts at least 30 days before submission for publication or 10 days before public presentation. After that time, Investigator is free to submit the manuscript for publication or deliver the presentation, provided Investigator removes any confidential information as directed by Curatek.
• Publication restrictions are in place

Restriction type: OTHER