Trial Outcomes & Findings for A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women (NCT NCT02210689)

NCT ID: NCT02210689

Last Updated: 2020-01-28

Results Overview

Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows: 1. The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle, 2. The whiff test is negative for any amine ("fishy") odor, 3. The saline wet mount is negative for clue cells, 4. Vaginal fluid pH is \< 4.7, using pH paper that measures from 3.6 to 6.1. A Bacteriological cure is defined as a Nugent score \< 4. The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field: 1. Lactobacillus: large gram positive rods, 2. Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods, 3. Mobiluncus spp.: thin, curved Gram variable rods

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 604 participants
• Primary outcome timeframe: 22 to 30 days
• Results posted on: 2020-01-28

Participant Flow

The populations for this study included the Safety Population, the Per-Protocol (PP) Population, and the Modified Intent-to-treat (mITT) Population.

Participant milestones

Measure	Generic Clindamycin Phosphate Vaginal Cream 2% One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	Clindesse (Clindamycin Phosphate Vaginal Cream 2%) One single-dose, pre-filled, disposable applicator of Investigational product to be administered intravaginally at home.	Vehicle Cream One single-dose, pre-filled, disposable applicator of Investigational product was to be inserted intravaginally at home.
Overall Study STARTED	242	240	122
Overall Study Safety Population	233	236	122
Overall Study mITT Population	199	207	107
Overall Study PP Population	164	169	84
Overall Study COMPLETED	190	193	99
Overall Study NOT COMPLETED	52	47	23

Reasons for withdrawal

Measure	Generic Clindamycin Phosphate Vaginal Cream 2% One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	Clindesse (Clindamycin Phosphate Vaginal Cream 2%) One single-dose, pre-filled, disposable applicator of Investigational product to be administered intravaginally at home.	Vehicle Cream One single-dose, pre-filled, disposable applicator of Investigational product was to be inserted intravaginally at home.
Overall Study Withdrawal by Subject	7	4	2
Overall Study Adverse Event	0	1	0
Overall Study Protocol Violation	1	0	0
Overall Study Lost to Follow-up	11	9	5
Overall Study Pregnancy	0	1	0
Overall Study Lack of Efficacy	0	1	5
Overall Study Prohibited medication	2	8	1
Overall Study Negative Nugent score at baseline	6	2	2
Overall Study Other	25	21	8

Baseline Characteristics

A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women

Baseline characteristics by cohort

Measure	Generic Clindamycin Phosphate Vaginal Cream 2% n=233 Participants One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	Clindesse (Clindamycin Phosphate Vaginal Cream 2%) n=236 Participants One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	Vehicle Cream n=122 Participants One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	Total n=591 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 9.66 • n=5 Participants	35.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	35.1 years STANDARD_DEVIATION 10.17 • n=5 Participants	35.1 years STANDARD_DEVIATION 9.98 • n=4 Participants
Sex: Female, Male Female	233 Participants n=5 Participants	236 Participants n=7 Participants	122 Participants n=5 Participants	591 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=5 Participants	49 Participants n=7 Participants	26 Participants n=5 Participants	120 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	188 Participants n=5 Participants	187 Participants n=7 Participants	96 Participants n=5 Participants	471 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Black or African American	94 Participants n=5 Participants	106 Participants n=7 Participants	55 Participants n=5 Participants	255 Participants n=4 Participants
Race (NIH/OMB) White	126 Participants n=5 Participants	120 Participants n=7 Participants	58 Participants n=5 Participants	304 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment United States	233 participants n=5 Participants	236 participants n=7 Participants	122 participants n=5 Participants	591 participants n=4 Participants

PRIMARY outcome

Timeframe: 22 to 30 days

Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:

1. The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,

2. The whiff test is negative for any amine ("fishy") odor,

3. The saline wet mount is negative for clue cells,

4. Vaginal fluid pH is < 4.7, using pH paper that measures from 3.6 to 6.1.

A Bacteriological cure is defined as a Nugent score < 4.

The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:

1. Lactobacillus: large gram positive rods,

2. Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,

3. Mobiluncus spp.: thin, curved Gram variable rods

Outcome measures

Measure	Test Product n=164 Participants One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) clindamycin phosphate vaginal cream 2%	Reference Product n=169 Participants One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™) clindamycin phosphate vaginal cream 2%	Placebo n=84 Participants One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.) placebo: vehicle used as placebo
Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).	36 Participants	34 Participants	9 Participants

Adverse Events

Generic Clindamycin Phosphate Vaginal Cream 2%

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

Clindesse (Clindamycin Phosphate Vaginal Cream 2%)

Serious events: 0 serious events

Other events: 79 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Generic Clindamycin Phosphate Vaginal Cream 2% n=233 participants at risk One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	Clindesse (Clindamycin Phosphate Vaginal Cream 2%) n=236 participants at risk One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	Vehicle Cream n=122 participants at risk One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
Reproductive system and breast disorders Vulvovaginal burning sensation	2.1% 5/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.7% 4/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vulvovaginal discomfort	1.7% 4/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.7% 4/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vulvovaginal erythema	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.3% 3/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vulvovaginal pain	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vulvovaginal pruritus	4.7% 11/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	6.8% 16/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	4.1% 5/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vulvovaginal rash	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vulvovaginal swelling	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.3% 3/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Skin and subcutaneous tissue disorders Acne	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Skin and subcutaneous tissue disorders Miliaria	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Skin and subcutaneous tissue disorders Urticaria	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Uterine spasm	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Vascular disorders Thrombosis	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vaginal discharge	3.0% 7/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	6.4% 15/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	4.1% 5/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vaginal haemorrhage	1.7% 4/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.3% 3/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Vaginal odour	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.85% 2/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	3.3% 4/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye Disorder	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye Irritation	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Eye disorders Eye pruritus	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Abdominal distension	0.86% 2/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Abdominal pain	4.7% 11/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	4.7% 11/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	4.9% 6/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Abdominal pain lower	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.85% 2/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	3.3% 4/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.3% 3/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Abdominal tenderness	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Constipation	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Dental caries	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Diarrhoea	1.7% 4/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.85% 2/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	3.3% 4/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Flatulence	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Nausea	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.3% 3/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.6% 2/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Toothache	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Gastrointestinal disorders Vomiting	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
General disorders Chills	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
General disorders Fatigue	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
General disorders Pyrexia	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Bacterial infection	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Candida infection	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Fungal infection	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.3% 3/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Influenza	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Lower respiratory tract infection	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Nasopharyngitis	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.7% 4/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	2.5% 3/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Oral Herpes	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Pharyngitis	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Sinusitis	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Tooth infection	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Upper respiratory tract infection	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.85% 2/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Urinary tract infection	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.85% 2/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Infections and infestations Vulvovaginal mycotic infection	2.1% 5/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	3.8% 9/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Injury, poisoning and procedural complications Arthropod bite	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Investigations Body temperature increased	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Arthropathy	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.6% 2/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.86% 2/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Neoplams benign, malignant and unspecified	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Musculoskeletal and connective tissue disorders Uterine leiomyoma	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Dizziness	0.86% 2/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.3% 3/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.6% 2/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Headache	5.6% 13/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	6.4% 15/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	10.7% 13/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Migraine	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Nervous system disorders Tension headache	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Psychiatric disorders Depression	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Psychiatric disorders Mood altered	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Renal and urinary disorders Chromaturia	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.42% 1/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Renal and urinary disorders Dysuria	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.85% 2/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.6% 2/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Renal and urinary disorders Pollakiuria	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.6% 2/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Breast mass	0.43% 1/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Dysmenorrhoea	1.7% 4/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.7% 4/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.82% 1/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.
Reproductive system and breast disorders Pelvic pain	0.00% 0/233 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	0.00% 0/236 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.	1.6% 2/122 • Baseline to 30 days Adverse events were collected from participants who were randomized and received the study drug.

Additional Information

Senior Director, CE Studies

Teva Pharmaceuticals USA. Inc.

Phone: 1-888-483-8279

Email: USMedInfo@tevapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
• Publication restrictions are in place

Restriction type: OTHER