Trial Outcomes & Findings for Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis (NCT NCT00803738)

NCT ID: NCT00803738

Last Updated: 2021-10-13

Results Overview

The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 572 participants
• Primary outcome timeframe: Visit 3: Day 22-31
• Results posted on: 2021-10-13

Participant Flow

Patients were recruited at 31 dermatology clinical practices.

Participant milestones

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Overall Study STARTED	286	286
Overall Study COMPLETED	192	176
Overall Study NOT COMPLETED	94	110

Reasons for withdrawal

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Overall Study Adverse Event	3	5
Overall Study Lost to Follow-up	4	4
Overall Study Protocol Violation	18	10
Overall Study Withdrawal by Subject	1	4
Overall Study Lack of Efficacy	10	16
Overall Study Negative Baseline Culture of Candida	56	63
Overall Study Positive Results for STD or abnormal PAP	2	8

Baseline Characteristics

Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

Baseline characteristics by cohort

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo n=286 Participants Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg n=286 Participants Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days	Total n=572 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	278 Participants n=5 Participants	276 Participants n=7 Participants	554 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	33.4 years STANDARD_DEVIATION 13.3 • n=5 Participants	31.6 years STANDARD_DEVIATION 13.1 • n=7 Participants	32.5 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	286 Participants n=5 Participants	286 Participants n=7 Participants	572 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	286 participants n=5 Participants	286 participants n=7 Participants	572 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 3: Day 22-31

Population: Per Protocol (PP) population

The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.

Outcome measures

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo n=153 Participants Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg n=147 Participants Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Proportion of Subjects in Each Treatment Group With Therapeutic Cure	105 participants Interval -4.3 to 15.02	93 participants Interval -4.3 to 15.02

SECONDARY outcome

Timeframe: Visit 3: Day 22-31

Population: Per protocol population

Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.

Outcome measures

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo n=153 Participants Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg n=147 Participants Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Proportion of Subjects With Mycological Cure	127 participants	117 participants

SECONDARY outcome

Timeframe: Visit 3: Day 22-31

Population: per protocol population

A subject was considered a clinical cure if all of the following were satisfied:

1. All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.

2. Total signs and symptoms did not worsen at any time following completion of the study treatment.

3. Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.

4. The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.

5. The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products

Outcome measures

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo n=153 Participants Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg n=147 Participants Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Proportion of Subjects With Clinical Cure	117 participants	101 participants

Adverse Events

Terconazole Vaginal Suppositories, 80 mg - Perrigo

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Terazol 3 - Terconazole Vaginal Suppositories 80 mg

Serious events: 1 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo n=282 participants at risk Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg n=275 participants at risk Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Infections and infestations appendicitis	0.00% 0/282 • Up to day 31 Incidence of AEs during the study was summarized by treatment group. Frequency of all AEs was tabulated by treatment group, COSTART body system, severity, and relationship to the study medication. The differences between the treatment groups were compared using statistical measures. The analyses were conducted in the ITT population only.	0.36% 1/275 • Number of events 1 • Up to day 31 Incidence of AEs during the study was summarized by treatment group. Frequency of all AEs was tabulated by treatment group, COSTART body system, severity, and relationship to the study medication. The differences between the treatment groups were compared using statistical measures. The analyses were conducted in the ITT population only.

Other adverse events

Measure	Terconazole Vaginal Suppositories, 80 mg - Perrigo n=282 participants at risk Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days	Terazol 3 - Terconazole Vaginal Suppositories 80 mg n=275 participants at risk Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Nervous system disorders headache	12.8% 36/282 • Number of events 36 • Up to day 31 Incidence of AEs during the study was summarized by treatment group. Frequency of all AEs was tabulated by treatment group, COSTART body system, severity, and relationship to the study medication. The differences between the treatment groups were compared using statistical measures. The analyses were conducted in the ITT population only.	14.2% 39/275 • Number of events 39 • Up to day 31 Incidence of AEs during the study was summarized by treatment group. Frequency of all AEs was tabulated by treatment group, COSTART body system, severity, and relationship to the study medication. The differences between the treatment groups were compared using statistical measures. The analyses were conducted in the ITT population only.
Infections and infestations infection	4.3% 12/282 • Number of events 12 • Up to day 31 Incidence of AEs during the study was summarized by treatment group. Frequency of all AEs was tabulated by treatment group, COSTART body system, severity, and relationship to the study medication. The differences between the treatment groups were compared using statistical measures. The analyses were conducted in the ITT population only.	5.5% 15/275 • Number of events 15 • Up to day 31 Incidence of AEs during the study was summarized by treatment group. Frequency of all AEs was tabulated by treatment group, COSTART body system, severity, and relationship to the study medication. The differences between the treatment groups were compared using statistical measures. The analyses were conducted in the ITT population only.

Additional Information

Jonathan Schwartz

Perrigo Pharmaceuticals

Phone: 718-960-0119

Email: jonathan.schwartz@perrigo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER