Trial Outcomes & Findings for VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2 (NCT NCT00306293)
NCT ID: NCT00306293
Last Updated: 2018-03-23
Results Overview
Each participant's study day were classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab are positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits. Percent of days with HSV-2 shedding was defined for each participant as the percent of days with PCR data for which HSV-2 shedding was detected by a positive PCR result, i.e., the number of days with HSV-2 PCR shedding divided by total number of days with PCR data, multiplied by 100. Sum of the percent clinical and nonclinical shedding days was reported as total shedding. Mean percent of days with HSV-2 shedding was reported for each treatment group.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
Up to 60 days in each treatment period (Up to 148 days)
Results posted on
2018-03-23
Participant Flow
Seventy participants were enrolled at 14 centers in the United States. The study was conducted between 20 February 2006 and 28 November 2006.
Out of the 70 participants 35 participants were randomized to the VALTREX 1 g First then Placebo treatment sequence (VAL-PBO) and 35 participants were randomized to the Placebo first then VALTREX 1 g treatment sequence (PBO-VAL).
Participant milestones
| Measure |
VALTREX 1 g First Then Placebo
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days.
|
Placebo First Then VALTREX 1 g
Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Period 1 (Day 1 to Day 60)
STARTED
|
35
|
35
|
|
Period 1 (Day 1 to Day 60)
COMPLETED
|
27
|
27
|
|
Period 1 (Day 1 to Day 60)
NOT COMPLETED
|
8
|
8
|
|
Washout (Day 61 to Day 66)
STARTED
|
27
|
27
|
|
Washout (Day 61 to Day 66)
COMPLETED
|
27
|
27
|
|
Washout (Day 61 to Day 66)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Day 67 to Day 126 )
STARTED
|
27
|
27
|
|
Period 2 (Day 67 to Day 126 )
COMPLETED
|
24
|
26
|
|
Period 2 (Day 67 to Day 126 )
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
VALTREX 1 g First Then Placebo
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days.
|
Placebo First Then VALTREX 1 g
Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Period 1 (Day 1 to Day 60)
Adverse Event
|
1
|
0
|
|
Period 1 (Day 1 to Day 60)
Lost to Follow-up
|
3
|
4
|
|
Period 1 (Day 1 to Day 60)
Withdrawal by Subject
|
2
|
2
|
|
Period 1 (Day 1 to Day 60)
Positive pregnancy Test
|
2
|
2
|
|
Period 2 (Day 67 to Day 126 )
Adverse Event
|
1
|
0
|
|
Period 2 (Day 67 to Day 126 )
Lost to Follow-up
|
1
|
0
|
|
Period 2 (Day 67 to Day 126 )
Participant determined HSV-2 negative
|
0
|
1
|
|
Period 2 (Day 67 to Day 126 )
Pregnancy
|
1
|
0
|
Baseline Characteristics
VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
Baseline characteristics by cohort
| Measure |
Overall Study
n=70 Participants
Participants received VALTREX 1 g (2 x500 mg caplets) and matching placebo 2 caplets, orally, OD, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|
|
Age, Continuous
|
30.9 Year
STANDARD_DEVIATION 9.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 days in each treatment period (Up to 148 days)Population: Intent to Treat Crossover population comprised of all participants in the Intent to Treat population who had at least one PCR swabbing result in each Treatment Period. Intent to Treat population comprised of all participants who received at least one dose of investigational product.
Each participant's study day were classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab are positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits. Percent of days with HSV-2 shedding was defined for each participant as the percent of days with PCR data for which HSV-2 shedding was detected by a positive PCR result, i.e., the number of days with HSV-2 PCR shedding divided by total number of days with PCR data, multiplied by 100. Sum of the percent clinical and nonclinical shedding days was reported as total shedding. Mean percent of days with HSV-2 shedding was reported for each treatment group.
Outcome measures
| Measure |
VALTREX 1 g, OD
n=52 Participants
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=52 Participants
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Mean Percent Days of Total Shedding (Clinical and Subclinical) as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for Herpes Simplex Virus Type 2 (HSV-2)
|
2.9 Percent of days
Standard Deviation 5.6
|
13.5 Percent of days
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: Up to 60 days in each treatment period (Up to 148 days)Population: Intent-to-Treat Crossover
The percent of days with subclinical HSV-2 shedding was defined as the percent of all days with PCR data for which subclinical HSV-2 shedding was detected (shedding in the absence of a genital lesion). Mean percent of days with subclinical HSV-2 shedding was reported for each treatment group. Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits.
Outcome measures
| Measure |
VALTREX 1 g, OD
n=52 Participants
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=52 Participants
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Mean Percent Days Subclinical Shedding (no Genital Lesions Present)
|
2.4 Percentage of days
Standard Deviation 4.8
|
11 Percentage of days
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Up to 60 days in each treatment period (Up to 148 days)Population: Intent-to-Treat Crossover
The percent of days with clinical HSV-2 shedding was defined as the percent of all days with PCR data for which clinical HSV-2 shedding was detected (shedding in the presence of a genital lesion). Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits. Mean percent of days with clinical HSV-2 shedding was reported for each treatment group.
Outcome measures
| Measure |
VALTREX 1 g, OD
n=52 Participants
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=52 Participants
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Mean Percent Days Clinical Shedding (Presence of Genital Lesions)
|
0.6 Percentage of Days
Standard Deviation 1.7
|
2.4 Percentage of Days
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Up to 60 days in each treatment period (Up to 148 days)Population: Intent-to-Treat Crossover
The proportion of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data in the Treatment Period. Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits. Mean percent of days with no shedding was reported for each treatment group.
Outcome measures
| Measure |
VALTREX 1 g, OD
n=52 Participants
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=52 Participants
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Percentage of Participants With no Shedding
|
60 Percentage of participants
|
29 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 60 days in each treatment period (Up to 148 days)Population: Intent-to-Treat Crossover
The proportion of participants with at least one genital herpes recurrence was defined as the number of participants with at least one investigator-confirmed genital herpes recurrence divided by the total number of participants with at least one clinic visit in the treatment period.
Outcome measures
| Measure |
VALTREX 1 g, OD
n=52 Participants
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=52 Participants
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Percentage of Participants With at Least One Genital Herpes Recurrence
|
21 Percetage of participants
|
48 Percetage of participants
|
SECONDARY outcome
Timeframe: Up to Day 68Population: First Period Efficacy Population included participants in the Intent to Treat Exposed Population and was used for efficacy analyses restricted to the First Treatment Period.
Time to first genital herpes recurrence was evaluated using Kaplan-Meier estimates of investigator-confirmed genital herpes recurrences censoring the data from participants who prematurely discontinue the study at the time of discontinuation.
Outcome measures
| Measure |
VALTREX 1 g, OD
n=33 Participants
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=35 Participants
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Median Time to First Genital Herpes Recurrence (Days)
|
NA Days
Interval 11.0 to
Genital herpes did not recur in more than half of participants within the first treatment period. The analysis was restricted to Treatment Period I (60 days) + 7 days of Washout Period. Therefore the median and upper limit could not be estimated.
|
61 Days
Interval 4.0 to 61.0
|
SECONDARY outcome
Timeframe: Up to 148 daysPopulation: Intent to treat exposed population comprised of all participants who received at least one dose of investigational product.
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. No SAEs were reported in this study.
Outcome measures
| Measure |
VALTREX 1 g, OD
n=62 Participants
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=62 Participants
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Any AE
|
19 Participants
|
26 Participants
|
|
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Any SAE
|
0 Participants
|
0 Participants
|
Adverse Events
VALTREX 1 g, OD
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VALTREX 1 g, OD
n=62 participants at risk
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
Placebo
n=62 participants at risk
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
|
|---|---|---|
|
Infections and infestations
Fungal infection
|
4.8%
3/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
9.7%
6/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
3/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Sinusitis
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Vaginitis bacterial
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Bronchitis
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Ear infection
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Folliculitis
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Cervicitis human papilloma virus
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Labyrinthitis
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Onychomycosis
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Nervous system disorders
Headache
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Nervous system disorders
Migraine
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Investigations
Blood pressure increased
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Investigations
Smear cervix abnormal
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
3.2%
2/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Psychiatric disorders
Stress
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Renal and urinary disorders
Pollakiuria
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
1.6%
1/62 • AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER