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Varenicline for Adolescent Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01509547
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nicotine Dependence
Interventions Drug: Varenicline
Drug: placebo
Enrollment 157
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
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Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Period Title: Overall Study
Started 77 80
Completed 42 41
Not Completed 35 39
Reason Not Completed
Lost to Follow-up             24             14
Withdrawal by Subject             11             24
Physician Decision             0             1
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description

Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Total of all reporting groups
Overall Number of Baseline Participants 77 80 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 80 participants 157 participants
19.1  (1.5) 19.1  (1.4) 19.1  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 80 participants 157 participants
Female
28
  36.4%
35
  43.8%
63
  40.1%
Male
49
  63.6%
45
  56.3%
94
  59.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 80 participants 157 participants
Hispanic or Latino
3
   3.9%
1
   1.3%
4
   2.5%
Not Hispanic or Latino
74
  96.1%
79
  98.8%
153
  97.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 80 participants 157 participants
American Indian or Alaska Native
1
   1.3%
0
   0.0%
1
   0.6%
Asian
1
   1.3%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  14.3%
11
  13.8%
22
  14.0%
White
54
  70.1%
66
  82.5%
120
  76.4%
More than one race
8
  10.4%
3
   3.8%
11
   7.0%
Unknown or Not Reported
2
   2.6%
0
   0.0%
2
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants 80 participants 157 participants
77 80 157
1.Primary Outcome
Title Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment
Hide Description Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit
Time Frame 7 days at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Overall Number of Participants Analyzed 77 80
Measure Type: Count of Participants
Unit of Measure: Participants
4
   5.2%
4
   5.0%
2.Primary Outcome
Title Number of Participants Experiencing Treatment-emergent Adverse Events
Hide Description Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.
Time Frame 26 weeks (12 weeks of treatment plus full post-treatment follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Overall Number of Participants Analyzed 77 80
Measure Type: Count of Participants
Unit of Measure: Participants
55
  71.4%
60
  75.0%
3.Secondary Outcome
Title Percentage of Visits With Abstinence During Treatment
Hide Description Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence.
Time Frame 12 weeks (all of active treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Overall Number of Participants Analyzed 77 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of visits with abstinence
14.2
(11.9 to 16.4)
7.3
(5.6 to 8.9)
4.Secondary Outcome
Title Percentage of Post-treatment Visits With Abstinence
Hide Description Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence.
Time Frame One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Overall Number of Participants Analyzed 77 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of visits with abstinence
20.8
(14.4 to 27.2)
10.6
(5.8 to 15.4)
5.Secondary Outcome
Title Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment
Hide Description Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment
Time Frame 12 weeks of active treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Overall Number of Participants Analyzed 77 80
Measure Type: Count of Participants
Unit of Measure: Participants
31
  40.3%
24
  30.0%
Time Frame 6 months (randomization to last post-treatment follow-up visit)
Adverse Event Reporting Description Assessed and coded in MedDRA terminology by the medical clinician at each visit.
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description

Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Varenicline: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Participants >55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

placebo: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)      0/80 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/77 (0.00%)      0/80 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/77 (71.43%)      60/80 (75.00%)    
Ear and labyrinth disorders     
ear congestion  1  0/77 (0.00%)  0 1/80 (1.25%)  1
Eye disorders     
blurred vision  1  1/77 (1.30%)  1 0/80 (0.00%)  0
conjunctivitis  1  1/77 (1.30%)  1 0/80 (0.00%)  0
Gastrointestinal disorders     
abdominal pain  1  0/77 (0.00%)  0 1/80 (1.25%)  1
constipation  1  1/77 (1.30%)  1 1/80 (1.25%)  1
diarrhoea  1  2/77 (2.60%)  2 1/80 (1.25%)  1
dry mouth  1  0/77 (0.00%)  0 2/80 (2.50%)  2
dyspepsia  1  1/77 (1.30%)  1 0/80 (0.00%)  0
dyspepsia (worsening)  1  2/77 (2.60%)  2 1/80 (1.25%)  1
flatulence  1  0/77 (0.00%)  0 1/80 (1.25%)  1
GERD  1  1/77 (1.30%)  1 0/80 (0.00%)  0
gastritis  1  1/77 (1.30%)  1 0/80 (0.00%)  0
gastroenteritis  1  1/77 (1.30%)  1 3/80 (3.75%)  3
nausea  1  24/77 (31.17%)  28 15/80 (18.75%)  15
salivary hypersecretion  1  0/77 (0.00%)  0 1/80 (1.25%)  1
stomachache  1  3/77 (3.90%)  3 0/80 (0.00%)  0
stomatitis  1  1/77 (1.30%)  1 0/80 (0.00%)  0
vomiting  1  11/77 (14.29%)  15 6/80 (7.50%)  7
General disorders     
fatigue  1  1/77 (1.30%)  1 3/80 (3.75%)  3
chest pain  1  1/77 (1.30%)  1 1/80 (1.25%)  1
Infections and infestations     
boil  1  3/77 (3.90%)  5 0/80 (0.00%)  0
bronchitis  1  4/77 (5.19%)  4 2/80 (2.50%)  2
cellulitis  1  1/77 (1.30%)  1 1/80 (1.25%)  1
folliculitis  1  0/77 (0.00%)  0 1/80 (1.25%)  1
gastroenteritis  1  1/77 (1.30%)  1 2/80 (2.50%)  2
influenza  1  2/77 (2.60%)  2 0/80 (0.00%)  0
influenza like illness  1  1/77 (1.30%)  1 2/80 (2.50%)  2
laryngitis  1  0/77 (0.00%)  0 1/80 (1.25%)  1
lung infection  1  0/77 (0.00%)  0 1/80 (1.25%)  1
oral herpes  1  0/77 (0.00%)  0 1/80 (1.25%)  1
otitis media  1  0/77 (0.00%)  0 1/80 (1.25%)  1
pharyngitis  1  2/77 (2.60%)  2 4/80 (5.00%)  4
pneumonia  1  1/77 (1.30%)  1 0/80 (0.00%)  0
sinusitis  1  4/77 (5.19%)  4 1/80 (1.25%)  1
urinary tract infection  1  0/77 (0.00%)  0 1/80 (1.25%)  2
vaginal infection  1  0/77 (0.00%)  0 3/80 (3.75%)  3
viral upper respiratory tract infection  1  21/77 (27.27%)  25 13/80 (16.25%)  15
Injury, poisoning and procedural complications     
contusion  1  1/77 (1.30%)  1 0/80 (0.00%)  0
corneal abrasion  1  1/77 (1.30%)  1 0/80 (0.00%)  0
fracture  1  0/77 (0.00%)  0 1/80 (1.25%)  1
fractured coccyx  1  1/77 (1.30%)  1 0/80 (0.00%)  0
laceration  1  0/77 (0.00%)  0 2/80 (2.50%)  2
limb injury  1  0/77 (0.00%)  0 1/80 (1.25%)  1
pain in extremity  1  1/77 (1.30%)  1 0/80 (0.00%)  0
post operative pain  1  2/77 (2.60%)  2 0/80 (0.00%)  0
post procedural complication  1  1/77 (1.30%)  2 0/80 (0.00%)  0
post-traumatic pain  1  1/77 (1.30%)  1 1/80 (1.25%)  1
skin abrasion  1  2/77 (2.60%)  2 2/80 (2.50%)  2
sprained ankle  1  1/77 (1.30%)  1 1/80 (1.25%)  1
sunburn  1  0/77 (0.00%)  0 1/80 (1.25%)  2
Metabolism and nutrition disorders     
decreased appetite  1  2/77 (2.60%)  2 0/80 (0.00%)  0
increased appetite  1  1/77 (1.30%)  1 3/80 (3.75%)  3
Musculoskeletal and connective tissue disorders     
back muscle spasms  1  0/77 (0.00%)  0 1/80 (1.25%)  1
back pain  1  0/77 (0.00%)  0 1/80 (1.25%)  1
costochondritis  1  1/77 (1.30%)  1 0/80 (0.00%)  0
foot pain  1  1/77 (1.30%)  1 1/80 (1.25%)  1
knee pain  1  2/77 (2.60%)  2 0/80 (0.00%)  0
pain in extremity  1  2/77 (2.60%)  2 0/80 (0.00%)  0
pain in jaw  1  0/77 (0.00%)  0 1/80 (1.25%)  1
shoulder pain  1  1/77 (1.30%)  1 0/80 (0.00%)  0
Nervous system disorders     
convulsion  1  1/77 (1.30%)  1 0/80 (0.00%)  0
dizziness  1  1/77 (1.30%)  1 1/80 (1.25%)  1
dysgeusia  1  1/77 (1.30%)  1 1/80 (1.25%)  1
headache  1  8/77 (10.39%)  8 9/80 (11.25%)  13
lightheadedness  1  1/77 (1.30%)  3 1/80 (1.25%)  2
memory impairment  1  0/77 (0.00%)  0 1/80 (1.25%)  1
migraine  1  0/77 (0.00%)  0 1/80 (1.25%)  2
migraine (worsening)  1  0/77 (0.00%)  0 1/80 (1.25%)  1
paraesthesia  1  1/77 (1.30%)  1 0/80 (0.00%)  0
poor quality sleep  1  3/77 (3.90%)  3 0/80 (0.00%)  0
somnolence  1  0/77 (0.00%)  0 1/80 (1.25%)  1
Psychiatric disorders     
agitation  1  8/77 (10.39%)  9 5/80 (6.25%)  6
anxiety  1  1/77 (1.30%)  1 3/80 (3.75%)  3
anxiety (worsening)  1  1/77 (1.30%)  1 1/80 (1.25%)  1
attention-deficit/hyperactivity disorder  1  1/77 (1.30%)  1 0/80 (0.00%)  0
depressed mood  1  3/77 (3.90%)  3 5/80 (6.25%)  5
hostility  1  1/77 (1.30%)  1 1/80 (1.25%)  1
hypervigilance  1  1/77 (1.30%)  1 0/80 (0.00%)  0
inappropriate affect  1  1/77 (1.30%)  1 0/80 (0.00%)  0
insomnia  1  9/77 (11.69%)  10 7/80 (8.75%)  7
irritability  1  0/77 (0.00%)  0 1/80 (1.25%)  1
mood swings  1  1/77 (1.30%)  1 2/80 (2.50%)  2
panic attack (worsening)  1  1/77 (1.30%)  2 0/80 (0.00%)  0
passive suicidal ideation  1  1/77 (1.30%)  1 3/80 (3.75%)  3
tobacco withdrawal symptoms  1  1/77 (1.30%)  1 0/80 (0.00%)  0
vivid dreams  1  10/77 (12.99%)  10 7/80 (8.75%)  7
Renal and urinary disorders     
dysuria  1  1/77 (1.30%)  1 0/80 (0.00%)  0
oliguria  1  0/77 (0.00%)  0 1/80 (1.25%)  1
Reproductive system and breast disorders     
dysmenorrhoea  1  2/77 (2.60%)  2 1/80 (1.25%)  1
menorrhagia  1  1/77 (1.30%)  1 0/80 (0.00%)  0
vaginal discharge  1  1/77 (1.30%)  1 0/80 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
asthma  1  3/77 (3.90%)  3 0/80 (0.00%)  0
chest congestion  1  0/77 (0.00%)  0 1/80 (1.25%)  1
cough  1  4/77 (5.19%)  4 8/80 (10.00%)  8
lung infection  1  1/77 (1.30%)  1 0/80 (0.00%)  0
nasal congestion  1  6/77 (7.79%)  7 4/80 (5.00%)  4
rhinitis seasonal (worsening)  1  0/77 (0.00%)  0 3/80 (3.75%)  3
sore throat  1  3/77 (3.90%)  3 4/80 (5.00%)  5
throat irritation  1  0/77 (0.00%)  0 1/80 (1.25%)  1
Skin and subcutaneous tissue disorders     
hyperhidrosis  1  0/77 (0.00%)  0 1/80 (1.25%)  1
night sweats  1  0/77 (0.00%)  0 1/80 (1.25%)  1
pruritus  1  2/77 (2.60%)  2 0/80 (0.00%)  0
rash generalized  1  0/77 (0.00%)  0 1/80 (1.25%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kevin M. Gray, M.D.
Organization: Medical University of South Carolina
Phone: 843-792-6330
Responsible Party: Kevin Gray, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01509547     History of Changes
Other Study ID Numbers: Pro00014398
First Submitted: December 14, 2011
First Posted: January 13, 2012
Results First Submitted: January 23, 2019
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019