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Trial record 88 of 10804 for:    Placebo AND once

VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.

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ClinicalTrials.gov Identifier: NCT00116844
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Infections, Herpesviridae
Interventions Drug: Valaciclovir
Drug: Placebo
Enrollment 73
Recruitment Details From March-2005 to January-2006, 73 participants from 13 centers in the United States were randomized into the study (36 in VALTREX™-Placebo, and 37 in Placebo-VALTEX treatment sequence). One participant in each treatment sequence did not receive study medication and intent-to-treat exposed (ITTE) population was comprised of 71 participants.
Pre-assignment Details Eligible male or female immunocompetent participants in general good health were enrolled. Additionally, participants must be Herpes Simplex Virus Type 2 (HSV-2) seropositive at screening. VALTREX (valacyclovir hydrochloride) is registered trademark of GlaxoSmithKline.
Arm/Group Title Sequence 1: VALTREX 1 g Once Daily, Placebo Sequence 2: Placebo, VALTREX 1 g Once Daily
Hide Arm/Group Description Participants randomized to this sequence received VALTREX 1 gram (g) once daily for 60 days, to be taken as two 500 milligram (mg) caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
Period Title: Period 1: Treatment Period 1 (60 Days)
Started 35 36
Completed 28 33
Not Completed 7 3
Reason Not Completed
Lost to Follow-up             1             1
Protocol Violation             0             1
Withdrawal by Subject             5             0
Other             1             1
Period Title: Period 2: Washout Period (7 Days)
Started 28 33
Completed 28 33
Not Completed 0 0
Period Title: Period 1: Treatment Period 2 (60 Days)
Started 28 33
Completed 24 28
Not Completed 4 5
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             2             1
Other             0             2
Protocol Violation             0             1
Withdrawal by Subject             1             1
Arm/Group Title Sequence 1: VALTREX 1 g Once Daily, Placebo Sequence 2: Placebo, VALTREX 1 g Once Daily Total
Hide Arm/Group Description Participants randomized to this sequence received VALTREX 1 g once daily for 60 days, to be taken as two 500 mg caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. Total of all reporting groups
Overall Number of Baseline Participants 35 36 71
Hide Baseline Analysis Population Description
The ITTE population was defined as consisting of all participants who received at least one dose of investigational product and at least one safety and/or efficacy evaluation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 36 participants 71 participants
39.1  (12.96) 35.8  (11.69) 37.4  (12.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
Female
24
  68.6%
29
  80.6%
53
  74.6%
Male
11
  31.4%
7
  19.4%
18
  25.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
American Indian or Alaska Native
0
   0.0%
1
   2.8%
1
   1.4%
Asian
0
   0.0%
1
   2.8%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  14.3%
14
  38.9%
19
  26.8%
White
28
  80.0%
19
  52.8%
47
  66.2%
More than one race
1
   2.9%
1
   2.8%
2
   2.8%
Unknown or Not Reported
1
   2.9%
0
   0.0%
1
   1.4%
1.Primary Outcome
Title Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
Hide Description Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Time Frame Up to Day 60 of each treatment period (up to 160 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat crossover (ITTC) population was defined as consisting of all participants who received at least one dose of investigational product and had at least one PCR swabbing result in each treatment period. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title VALTREX 1 g Once Daily Placebo
Hide Arm/Group Description:
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Percentage of days
1.5  (5.3) 5.1  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Nonparametric tests-Wilcoxon Rank Sum
Comments [Not Specified]
2.Secondary Outcome
Title Mean Percent Days of Total HSV-2 Shedding
Hide Description The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Time Frame Up to Day 60 of each treatment period (up to 160 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTC population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title VALTREX 1 g Once Daily Placebo
Hide Arm/Group Description:
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: Percentage of days
1.5  (5.2) 5.5  (9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Nonparametric tests-Wilcoxon Rank Sum
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With no Shedding
Hide Description The number 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. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Time Frame Up to Day 60 of each treatment period (up to 160 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTC population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title VALTREX 1 g Once Daily Placebo
Hide Arm/Group Description:
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Overall Number of Participants Analyzed 56 56
Measure Type: Count of Participants
Unit of Measure: Participants
No Shedding
47
  83.9%
30
  53.6%
Shedding
9
  16.1%
26
  46.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Prescott’s method
Comments [Not Specified]
4.Secondary Outcome
Title Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding
Hide Description The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Time Frame Up to Day 60 of each treatment period (up to 160 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTC population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title VALTREX 1 g Once Daily Placebo
Hide Arm/Group Description:
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: DNA copies per day
4.5  (0.9) 4.6  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.800
Comments [Not Specified]
Method Nonparametric tests-Wilcoxon Rank Sum
Comments [Not Specified]
5.Secondary Outcome
Title Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding
Hide Description The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Time Frame Up to Day 60 of each treatment period (up to 160 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTC population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title VALTREX 1 g Once Daily Placebo
Hide Arm/Group Description:
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: DNA copies per day
4.5  (0.9) 5.2  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments [Not Specified]
Method Nonparametric tests-Wilcoxon Rank Sum
Comments [Not Specified]
6.Secondary Outcome
Title Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
Hide Description Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits.
Time Frame Up to Day 60 of each treatment period (up to 160 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITTC population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title VALTREX 1 g Once Daily Placebo
Hide Arm/Group Description:
Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
Overall Number of Participants Analyzed 56 56
Measure Type: Number
Unit of Measure: Percentage of participants
No Signs/Symptoms 88 77
Signs/symptoms Present 13 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g Once Daily, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0331
Comments [Not Specified]
Method Prescott’s method
Comments [Not Specified]
Time Frame Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 160 days)
Adverse Event Reporting Description The ITTE population was used.
 
Arm/Group Title Valtrex 1 g Once Daily Placebo
Hide Arm/Group Description Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods. Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
All-Cause Mortality
Valtrex 1 g Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/63 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Valtrex 1 g Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   1/63 (1.59%) 
Injury, poisoning and procedural complications     
Lower limb fracture  1  0/65 (0.00%)  1/63 (1.59%) 
Nervous system disorders     
Loss of consciousness  1  0/65 (0.00%)  1/63 (1.59%) 
1
Term from vocabulary, MedDRA version
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Valtrex 1 g Once Daily Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   29/65 (44.62%)   42/63 (66.67%) 
Cardiac disorders     
Tachycardia  1  0/65 (0.00%)  1/63 (1.59%) 
Eye disorders     
Eye discharge  1  0/65 (0.00%)  1/63 (1.59%) 
Gastrointestinal disorders     
Diarrhoea  1  2/65 (3.08%)  2/63 (3.17%) 
Nausea  1  3/65 (4.62%)  1/63 (1.59%) 
Toothache  1  0/65 (0.00%)  3/63 (4.76%) 
Stomach discomfort  1  1/65 (1.54%)  1/63 (1.59%) 
Vomiting  1  0/65 (0.00%)  2/63 (3.17%) 
Abdominal distension  1  1/65 (1.54%)  0/63 (0.00%) 
Abdominal pain lower  1  1/65 (1.54%)  0/63 (0.00%) 
Constipation  1  0/65 (0.00%)  1/63 (1.59%) 
Dyspepsia  1  1/65 (1.54%)  0/63 (0.00%) 
Gastrooesophageal reflux disease  1  1/65 (1.54%)  0/63 (0.00%) 
Haematochezia  1  0/65 (0.00%)  1/63 (1.59%) 
Oral soft tissue disorder  1  1/65 (1.54%)  0/63 (0.00%) 
General disorders     
Fatigue  1  2/65 (3.08%)  0/63 (0.00%) 
Influenza like illness  1  0/65 (0.00%)  1/63 (1.59%) 
Malaise  1  1/65 (1.54%)  0/63 (0.00%) 
Oedema peripheral  1  0/65 (0.00%)  1/63 (1.59%) 
Pyrexia  1  0/65 (0.00%)  1/63 (1.59%) 
Infections and infestations     
Upper respiratory tract infection  1  2/65 (3.08%)  8/63 (12.70%) 
Nasopharyngitis  1  2/65 (3.08%)  5/63 (7.94%) 
Vaginitis bacterial  1  1/65 (1.54%)  3/63 (4.76%) 
Folliculitis  1  0/65 (0.00%)  3/63 (4.76%) 
Gastroenteritis viral  1  1/65 (1.54%)  1/63 (1.59%) 
Sinusitis  1  1/65 (1.54%)  1/63 (1.59%) 
Urinary tract infection  1  1/65 (1.54%)  1/63 (1.59%) 
Bronchitis  1  0/65 (0.00%)  1/63 (1.59%) 
Bronchitis viral  1  1/65 (1.54%)  0/63 (0.00%) 
Candidiasis  1  0/65 (0.00%)  1/63 (1.59%) 
Fungal infection  1  0/65 (0.00%)  1/63 (1.59%) 
Furuncle  1  1/65 (1.54%)  0/63 (0.00%) 
Gastroenteritis  1  0/65 (0.00%)  1/63 (1.59%) 
Herpes simplex  1  0/65 (0.00%)  1/63 (1.59%) 
Hordeolum  1  0/65 (0.00%)  1/63 (1.59%) 
Kidney infection  1  0/65 (0.00%)  1/63 (1.59%) 
Oral candidiasis  1  0/65 (0.00%)  1/63 (1.59%) 
Otitis media  1  0/65 (0.00%)  1/63 (1.59%) 
Pelvic inflammatory disease  1  1/65 (1.54%)  0/63 (0.00%) 
Pharyngitis  1  0/65 (0.00%)  1/63 (1.59%) 
Pneumonia  1  0/65 (0.00%)  1/63 (1.59%) 
Rhinitis  1  0/65 (0.00%)  1/63 (1.59%) 
Vulvovaginal mycotic infection  1  0/65 (0.00%)  1/63 (1.59%) 
Injury, poisoning and procedural complications     
Muscle strain  1  0/65 (0.00%)  2/63 (3.17%) 
Contusion  1  0/65 (0.00%)  1/63 (1.59%) 
Failure of implant  1  0/65 (0.00%)  1/63 (1.59%) 
Joint injury  1  0/65 (0.00%)  1/63 (1.59%) 
Laceration  1  0/65 (0.00%)  1/63 (1.59%) 
Neck injury  1  0/65 (0.00%)  1/63 (1.59%) 
Investigations     
Blood urine present  1  1/65 (1.54%)  0/63 (0.00%) 
Eosinophil count increased  1  1/65 (1.54%)  0/63 (0.00%) 
Metamyelocyte count increased  1  1/65 (1.54%)  0/63 (0.00%) 
Myelocyte count increased  1  1/65 (1.54%)  0/63 (0.00%) 
Weight increased  1  0/65 (0.00%)  1/63 (1.59%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  2/65 (3.08%)  2/63 (3.17%) 
Musculoskeletal stiffness  1  1/65 (1.54%)  0/63 (0.00%) 
Plantar fasciitis  1  1/65 (1.54%)  0/63 (0.00%) 
Shoulder pain  1  1/65 (1.54%)  0/63 (0.00%) 
Nervous system disorders     
Headache  1  3/65 (4.62%)  4/63 (6.35%) 
Dizziness  1  4/65 (6.15%)  1/63 (1.59%) 
Migraine  1  2/65 (3.08%)  1/63 (1.59%) 
Tension headache  1  1/65 (1.54%)  0/63 (0.00%) 
Psychiatric disorders     
Insomnia  1  0/65 (0.00%)  1/63 (1.59%) 
Renal and urinary disorders     
Dysuria  1  1/65 (1.54%)  0/63 (0.00%) 
Pollakiuria  1  0/65 (0.00%)  1/63 (1.59%) 
Proteinuria  1  0/65 (0.00%)  1/63 (1.59%) 
Reproductive system and breast disorders     
Breast tenderness  1  1/65 (1.54%)  0/63 (0.00%) 
Erectile dysfunction  1  1/65 (1.54%)  0/63 (0.00%) 
Metrorrhagia  1  1/65 (1.54%)  0/63 (0.00%) 
Pelvic pain  1  1/65 (1.54%)  0/63 (0.00%) 
Vaginal discharge  1  1/65 (1.54%)  0/63 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  0/65 (0.00%)  1/63 (1.59%) 
Pharyngolaryngeal pain  1  0/65 (0.00%)  1/63 (1.59%) 
Productive cough  1  1/65 (1.54%)  0/63 (0.00%) 
Throat irritation  1  0/65 (0.00%)  1/63 (1.59%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  1/65 (1.54%)  0/63 (0.00%) 
Pruritus  1  1/65 (1.54%)  0/63 (0.00%) 
Pruritus allergic  1  1/65 (1.54%)  0/63 (0.00%) 
1
Term from vocabulary, MedDRA version
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00116844     History of Changes
Obsolete Identifiers: NCT00268190
Other Study ID Numbers: VLX103596
First Submitted: June 30, 2005
First Posted: July 1, 2005
Results First Submitted: March 16, 2017
Results First Posted: February 12, 2018
Last Update Posted: February 12, 2018