Trial Outcomes & Findings for Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women (NCT NCT01230814)
NCT ID: NCT01230814
Last Updated: 2014-10-06
Results Overview
Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
Months 2, 4, 6, 8, 10, and 12.
Results posted on
2014-10-06
Participant Flow
Participant milestones
| Measure |
Arm 1: Metronidazole Plus Miconazole
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
116
|
|
Overall Study
COMPLETED
|
105
|
112
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
Arm 1: Metronidazole Plus Miconazole
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
3
|
|
Overall Study
Discontinued (not due to adverse event)
|
2
|
1
|
Baseline Characteristics
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Baseline characteristics by cohort
| Measure |
Arm 1: Metronidazole Plus Miconazole
n=118 Participants
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
n=116 Participants
Placebo suppositories nightly for five consecutive nights each month.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
29 years
n=7 Participants
|
29 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
117 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
118 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
233 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
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
89 participants
n=5 Participants
|
87 participants
n=7 Participants
|
176 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 2, 4, 6, 8, 10, and 12.Population: Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.
Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar.
Outcome measures
| Measure |
Arm 1: Metronidazole Plus Miconazole
n=645 Follow-up visits
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
n=665 Follow-up visits
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC).
|
10.4 percentage of follow-up visits
Interval 8.2 to 13.2
|
11.3 percentage of follow-up visits
Interval 9.0 to 14.1
|
PRIMARY outcome
Timeframe: Months 2, 4, 6, 8, 10, and 12.Population: Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.
Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV as determined by applying standard microscopic scoring criteria (Nugent's criteria) to vaginal Gram stained slides. BV is diagnosed when the score is greater than or equal to 7.
Outcome measures
| Measure |
Arm 1: Metronidazole Plus Miconazole
n=645 Follow-up Visits
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
n=665 Follow-up Visits
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV).
|
21.2 percentage of follow-up visits
Interval 18.0 to 25.1
|
32.5 percentage of follow-up visits
Interval 28.4 to 37.1
|
SECONDARY outcome
Timeframe: Months 2, 4, 6, 8, 10, and 12.Population: Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.
Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for any of three vaginal infections (BV, VVC, Trichomonas vaginalis infection).
Outcome measures
| Measure |
Arm 1: Metronidazole Plus Miconazole
n=645 Follow-up visits
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
n=665 Follow-up visits
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection).
|
32.6 percentage of follow-up visits
Interval 28.4 to 37.3
|
46.5 percentage of follow-up visits
Interval 41.6 to 51.9
|
SECONDARY outcome
Timeframe: Months 2, 4, 6, 8, 10, and 12.Population: Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.
Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV by clinical criteria (Amsel's criteria).
Outcome measures
| Measure |
Arm 1: Metronidazole Plus Miconazole
n=645 Follow-up visits
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
n=665 Follow-up visits
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel's Criteria).
|
14.4 percentage of follow-up visits
Interval 11.8 to 17.7
|
18.2 percentage of follow-up visits
Interval 15.2 to 21.7
|
Adverse Events
Arm 1: Metronidazole Plus Miconazole
Serious events: 3 serious events
Other events: 109 other events
Deaths: 0 deaths
Arm 2: Placebo
Serious events: 1 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Metronidazole Plus Miconazole
n=116 participants at risk
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
n=116 participants at risk
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.86%
1/116 • Number of events 1 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
0.00%
0/116 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue injury
|
0.86%
1/116 • Number of events 1 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
0.00%
0/116 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Infections and infestations
Malaria
|
0.86%
1/116 • Number of events 1 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
0.00%
0/116 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Infections and infestations
Typhoid fever
|
0.86%
1/116 • Number of events 1 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
0.00%
0/116 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Musculoskeletal and connective tissue disorders
Pelvic fracture
|
0.00%
0/116 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
0.86%
1/116 • Number of events 1 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
Other adverse events
| Measure |
Arm 1: Metronidazole Plus Miconazole
n=116 participants at risk
Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
|
Arm 2: Placebo
n=116 participants at risk
Placebo suppositories nightly for five consecutive nights each month.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
8/116 • Number of events 10 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
14.7%
17/116 • Number of events 21 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
12.1%
14/116 • Number of events 17 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
7.8%
9/116 • Number of events 12 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
10/116 • Number of events 11 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
7.8%
9/116 • Number of events 12 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.1%
21/116 • Number of events 25 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
9.5%
11/116 • Number of events 13 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Infections and infestations
Body tinea
|
6.9%
8/116 • Number of events 8 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.9%
8/116 • Number of events 10 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Cardiac disorders
Chest pain
|
6.9%
8/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.0%
7/116 • Number of events 8 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
6/116 • Number of events 8 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
10.3%
12/116 • Number of events 16 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
10/116 • Number of events 13 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
11.2%
13/116 • Number of events 17 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Gastrointestinal disorders
Gastroenteritis
|
7.8%
9/116 • Number of events 10 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.0%
7/116 • Number of events 7 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Nervous system disorders
Headache
|
20.7%
24/116 • Number of events 31 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
31.0%
36/116 • Number of events 53 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Nervous system disorders
Hypoaesthesia
|
10.3%
12/116 • Number of events 17 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
10.3%
12/116 • Number of events 19 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Infections and infestations
Malaria
|
6.0%
7/116 • Number of events 10 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
7.8%
9/116 • Number of events 11 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Reproductive system and breast disorders
Menorrhagia
|
7.8%
9/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.9%
8/116 • Number of events 8 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
7/116 • Number of events 7 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
8.6%
10/116 • Number of events 15 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Reproductive system and breast disorders
Nasopharyngitis
|
5.2%
6/116 • Number of events 11 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.0%
7/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
5/116 • Number of events 6 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.0%
7/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.2%
6/116 • Number of events 7 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.0%
7/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
7/116 • Number of events 7 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.0%
7/116 • Number of events 8 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
12.1%
14/116 • Number of events 14 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
15.5%
18/116 • Number of events 24 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
12.1%
14/116 • Number of events 16 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
8.6%
10/116 • Number of events 11 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue injury
|
6.9%
8/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
3.4%
4/116 • Number of events 5 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
7.8%
9/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.9%
8/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Gastrointestinal disorders
Toothache
|
6.9%
8/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
6.9%
8/116 • Number of events 10 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
34.5%
40/116 • Number of events 64 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
31.0%
36/116 • Number of events 54 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Renal and urinary disorders
Urinary tract infection
|
12.1%
14/116 • Number of events 24 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
10.3%
12/116 • Number of events 13 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
23.3%
27/116 • Number of events 55 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
37.1%
43/116 • Number of events 67 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Reproductive system and breast disorders
Vaginal odour
|
8.6%
10/116 • Number of events 19 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
4.3%
5/116 • Number of events 11 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
6.9%
8/116 • Number of events 13 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
5.2%
6/116 • Number of events 9 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
32.8%
38/116 • Number of events 62 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
37.9%
44/116 • Number of events 78 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
|
Reproductive system and breast disorders
Vulvovaginitis
|
16.4%
19/116 • Number of events 23 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
16.4%
19/116 • Number of events 27 • Months 2, 4, 6, 8, 10, and 12, and any interim visits.
Adverse events were followed until resolution even beyond the study-reporting period. Resolution of an adverse event is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
|
Additional Information
Shelly Lensing, MS
University of Arkansas for Medical Sciences
Phone: 501-686-8203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place