Trial Outcomes & Findings for Multi-Center Study of New Medications to Treat Vaginal Infections (NCT NCT02308046)

NCT ID: NCT02308046

Last Updated: 2020-07-27

Results Overview

The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 212 participants
• Primary outcome timeframe: 7-14 days after beginning treatment
• Results posted on: 2020-07-27

Participant Flow

Participant milestones

Measure	Terconazole Vaginal Gel One applicator full at bedtime Terconazole	Gel Vehicle One applicator full at bedtime Placebo
Overall Study STARTED	107	105
Overall Study COMPLETED	73	67
Overall Study NOT COMPLETED	34	38

Reasons for withdrawal

Measure	Terconazole Vaginal Gel One applicator full at bedtime Terconazole	Gel Vehicle One applicator full at bedtime Placebo
Overall Study Negative yeast culture at Baseline	32	33
Overall Study Positive for STD at Baseline	1	2
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Multi-Center Study of New Medications to Treat Vaginal Infections

Baseline characteristics by cohort

Measure	Terconazole Vaginal Gel n=73 Participants One applicator full at bedtime Terconazole	Gel Vehicle n=67 Participants One applicator full at bedtime Placebo	Total n=140 Participants Total of all reporting groups
Age, Continuous	33.4 years STANDARD_DEVIATION 12.24 • n=5 Participants	35.6 years STANDARD_DEVIATION 11.50 • n=7 Participants	34.4 years STANDARD_DEVIATION 11.91 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	67 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants	54 Participants n=7 Participants	116 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	73 participants n=5 Participants	67 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (positive baseline yeast culture and used at least one dose of study medication)

The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis

Outcome measures

Measure	Terconazole Vaginal Gel n=73 Participants One applicator full at bedtime Terconazole	Gel Vehicle n=67 Participants One applicator full at bedtime Placebo
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit	47 Participants	25 Participants

SECONDARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (positive baseline yeast culture and used at least one dose of study medication)

Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement.

Outcome measures

Measure	Terconazole Vaginal Gel n=73 Participants One applicator full at bedtime Terconazole	Gel Vehicle n=67 Participants One applicator full at bedtime Placebo
Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection	0.0 score on a scale Interval 0.0 to 18.0	3.0 score on a scale Interval 0.0 to 18.0

SECONDARY outcome

Timeframe: 7-14 days after beginning treatment and at 21-30 days after beginning treatment

Population: mITT population (positive baseline yeast culture and used at least one dose of study medication)

Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure.

Outcome measures

Measure	Terconazole Vaginal Gel n=73 Participants One applicator full at bedtime Terconazole	Gel Vehicle n=67 Participants One applicator full at bedtime Placebo
Mycologic Cure Candida culture cure at 21-30 days · Culture not taken	18 Participants	30 Participants
Mycologic Cure Candida culture cure at 7-14 days · Candia culture negative	57 Participants	6 Participants
Mycologic Cure Candida culture cure at 7-14 days · Candida culture positive	13 Participants	54 Participants
Mycologic Cure Candida culture cure at 7-14 days · Culture not taken	3 Participants	7 Participants
Mycologic Cure Candida culture cure at 21-30 days · Candia culture negative	31 Participants	7 Participants
Mycologic Cure Candida culture cure at 21-30 days · Candida culture positive	24 Participants	30 Participants

SECONDARY outcome

Timeframe: 7-14 days after beginning treatment

Population: mITT population (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=73 Participants One applicator full at bedtime Terconazole	Gel Vehicle n=67 Participants One applicator full at bedtime Placebo
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit	45 Participants	29 Participants

SECONDARY outcome

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

Population: The safety population includes 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=102 Participants One applicator full at bedtime Terconazole	Gel Vehicle n=99 Participants One applicator full at bedtime Placebo
Number of Participants With Treatment Emergent Adverse Events	39 Participants	38 Participants

Adverse Events

Terconazole Vaginal Gel

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Gel Vehicle

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Terconazole Vaginal Gel n=102 participants at risk One applicator full at bedtime Terconazole	Gel Vehicle n=99 participants at risk One applicator full at bedtime Placebo
Reproductive system and breast disorders Vulvovaginal burning sensation	6.9% 7/102 • Number of events 7 • 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. 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 at the baseline visit.	2.0% 2/99 • Number of events 2 • 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. 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 at the baseline visit.
Infections and infestations Bacterial vaginosis	8.8% 9/102 • Number of events 9 • 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. 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 at the baseline visit.	12.1% 12/99 • Number of events 12 • 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. 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 at the baseline visit.

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 Sponsor confidential information, Investigator shall submit to Sponsor 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 Sponsor.
• Publication restrictions are in place

Restriction type: OTHER