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Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)

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ClinicalTrials.gov Identifier: NCT01190514
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression - Major Depressive Disorder
Intervention Drug: desvenlafaxine succinate sustained release
Enrollment 41
Recruitment Details  
Pre-assignment Details Participants randomized to an open-label treatment sequence beginning in Period 1 with 25 milligrams as 2 tablets (25 mg*2) in fed state=A; or a 50 mg tablet in fed state=B; or 25 mg*2 tablets in fasted state=C; or a 50 mg tablet in fasted state=D in a cross-over, 4-period design. Treatment groups sequenced as: ABCD, BADC, CDAB, and DCBA.
Arm/Group Title DVS SR 25 mg*2 Fed (A) First DVS SR 50 mg Fed (B) First DVS SR 25 mg*2 Fasted (C) First DVS SR 50 mg Fasted (D) First
Hide Arm/Group Description Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing). DVS SR 50 mg tablet on Day 1 of study period in fed state. DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing). DVS SR 50 mg tablet on Day 1 of study period in fasted state.
Period Title: First Intervention (Period 1)
Started 11 10 10 10
Completed 10 [1] 10 10 10
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
[1]
Discontinued participant received treatment A of sequence ABCD.
Period Title: Second Intervention (Period 2)
Started 10 [1] 10 [2] 10 [3] 10 [4]
Completed 10 10 10 10
Not Completed 0 0 0 0
[1]
Period 2 received treatment B
[2]
Period 2 received treatment A
[3]
Period 2 received treatment D
[4]
Period 2 received treatment C
Period Title: Third Intervention (Period 3)
Started 10 [1] 10 [2] 10 [3] 10 [4]
Completed 9 [5] 10 10 10
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
[1]
Period 3 received treatment C
[2]
Period 3 received treatment D
[3]
Period 3 received treatment A
[4]
Period 3 received treatment B
[5]
Discontinued participant received treatments ABC of sequence ABCD.
Period Title: Fourth Intervention (Period 4)
Started 9 [1] 10 [2] 10 [3] 10 [4]
Completed 9 10 10 10
Not Completed 0 0 0 0
[1]
Period 4 received treatment D
[2]
Period 4 received treatment C
[3]
Period 4 received treatment B
[4]
Period 4 received treatment A
Arm/Group Title Entire Study Population
Hide Arm/Group Description Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg*2 Fasted (C); or DVS SR 50 mg Fasted (D).
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
37.6  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
21
  51.2%
Male
20
  48.8%
1.Primary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)
Hide Description Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).
Time Frame Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.
Arm/Group Title DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Hide Arm/Group Description:
DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
DVS SR 50 mg tablet on Day 1 of study period in fed state.
DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
Overall Number of Participants Analyzed 41 40 40 39
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
2948  (726.28) 2966  (836.52) 2632  (764.41) 2777  (893.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 25 mg*2 Fasted, DVS SR 50 mg Fasted
Comments

DVS SR 25 mg*2 fasted (test); DVS SR 50 mg fasted (reference).

Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio (%) of adjusted geometric means
Estimated Value 95.56
Confidence Interval (2-Sided) 90%
86.94 to 105.04
Estimation Comments Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS SR 25 mg*2 Fed, DVS SR 50 mg Fed
Comments

DVS SR 25 mg*2 fed (test); DVS SR 50 mg fed (reference).

Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio (%) of adjusted geometric means
Estimated Value 101.31
Confidence Interval (2-Sided) 90%
97.17 to 105.64
Estimation Comments Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg Fed, DVS SR 50 mg Fasted
Comments

Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).

Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio (%) of adjusted geometric means
Estimated Value 108.76
Confidence Interval (2-Sided) 90%
101.10 to 117.01
Estimation Comments Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description Cmax measured as nanograms divided by milliliters (ng/mL).
Time Frame Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population; N=number of participants contributing to the mean.
Arm/Group Title DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Hide Arm/Group Description:
DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
DVS SR 50 mg tablet on Day 1 of study period in fed state.
DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
Overall Number of Participants Analyzed 41 40 40 39
Mean (Standard Deviation)
Unit of Measure: ng/mL
130.6  (29.711) 131.0  (36.308) 107.3  (26.773) 112.1  (28.510)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DVS SR 25 mg*2 Fasted, DVS SR 50 mg Fasted
Comments

DVS SR 25 mg*2 fasted (test); DVS SR 50 mg fasted (reference).

Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (%) of adjusted geometric means
Estimated Value 95.10
Confidence Interval (2-Sided) 90%
89.37 to 101.20
Estimation Comments Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DVS SR 25 mg*2 Fed, DVS SR 50 mg Fed
Comments

DVS SR 25 mg*2 fed (test); DVS SR 50 mg fed (reference).

Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (%) of adjusted geometric means
Estimated Value 101.30
Confidence Interval (2-Sided) 90%
94.66 to 108.40
Estimation Comments Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection DVS SR 50 mg Fed, DVS SR 50 mg Fasted
Comments

Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).

Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio (%) of adjusted geometric means
Estimated Value 115.54
Confidence Interval (2-Sided) 90%
108.59 to 122.94
Estimation Comments Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).
3.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population; N=number of participants contributing to the median.
Arm/Group Title DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Hide Arm/Group Description:
DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
DVS SR 50 mg tablet on Day 1 of study period in fed state.
DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
Overall Number of Participants Analyzed 41 40 40 39
Median (Full Range)
Unit of Measure: hours
6.00
(4.00 to 12.0)
8.00
(2.00 to 12.0)
6.00
(4.00 to 16.0)
6.00
(4.00 to 24.0)
4.Secondary Outcome
Title Terminal Elimination Half-life (t 1/2)
Hide Description Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population; N=number of participants contributing to the median.
Arm/Group Title DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Hide Arm/Group Description:
DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
DVS SR 50 mg tablet on Day 1 of study period in fed state.
DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
Overall Number of Participants Analyzed 41 40 40 39
Mean (Standard Deviation)
Unit of Measure: hours
10.50  (2.2478) 10.72  (2.8931) 12.71  (6.0106) 11.13  (2.9444)
5.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)
Hide Description Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population; N=number of participants contributing to the mean.
Arm/Group Title DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Hide Arm/Group Description:
DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
DVS SR 50 mg tablet on Day 1 of study period in fed state.
DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
Overall Number of Participants Analyzed 41 40 40 39
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
3171  (820.37) 3216  (973.36) 3008  (1147.6) 3052  (1059.9)
6.Secondary Outcome
Title Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)
Hide Description [Not Specified]
Time Frame Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population; N=number of participants contributing to the mean.
Arm/Group Title DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Hide Arm/Group Description:
DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
DVS SR 50 mg tablet on Day 1 of study period in fed state.
DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
DVS SR 50 mg tablet on Day 1 of study period in fasted state.
Overall Number of Participants Analyzed 41 40 40 39
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
2948  (726.28) 2966  (836.47) 2631  (767.89) 2778  (894.03)
Time Frame Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Adverse Event Reporting Description Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
 
Arm/Group Title DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Hide Arm/Group Description DVS SR 25 mg*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing). DVS SR 50 mg tablet on Day 1 of study period in fed state. DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing). DVS SR 50 mg tablet on Day 1 of study period in fasted state.
All-Cause Mortality
DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DVS SR 25 mg*2 Fed DVS SR 50 mg Fed DVS SR 25 mg*2 Fasted DVS SR 50 mg Fasted
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/41 (46.34%)   19/40 (47.50%)   19/40 (47.50%)   16/39 (41.03%) 
Eye disorders         
Eyelid irritation * 1  1/41 (2.44%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  0/41 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%) 
Abdominal distension * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Diarrhoea * 1  2/41 (4.88%)  1/40 (2.50%)  1/40 (2.50%)  1/39 (2.56%) 
Dyspepsia * 1  1/41 (2.44%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%) 
Epigastric discomfort * 1  1/41 (2.44%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Flatulence * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Nausea * 1  2/41 (4.88%)  4/40 (10.00%)  0/40 (0.00%)  0/39 (0.00%) 
Salivary hypersecretion * 1  1/41 (2.44%)  1/40 (2.50%)  1/40 (2.50%)  1/39 (2.56%) 
Vomiting * 1  0/41 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%) 
General disorders         
Asthenia * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Fatigue * 1  2/41 (4.88%)  4/40 (10.00%)  3/40 (7.50%)  3/39 (7.69%) 
Hunger * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  2/39 (5.13%) 
Vessel puncture site haematoma * 1  1/41 (2.44%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%) 
Vessel puncture site pain * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  1/39 (2.56%) 
Infections and infestations         
Bronchitis * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Hordeolum * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  1/39 (2.56%) 
Nasopharyngitis * 1  0/41 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  1/39 (2.56%) 
Oral herpes * 1  0/41 (0.00%)  1/40 (2.50%)  1/40 (2.50%)  0/39 (0.00%) 
Urinary tract infection * 1  1/41 (2.44%)  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  1/41 (2.44%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/41 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  2/39 (5.13%) 
Musculoskeletal chest pain * 1  2/41 (4.88%)  2/40 (5.00%)  1/40 (2.50%)  1/39 (2.56%) 
Neck pain * 1  1/41 (2.44%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Pain in jaw * 1  1/41 (2.44%)  1/40 (2.50%)  1/40 (2.50%)  0/39 (0.00%) 
Nervous system disorders         
Dizziness * 1  0/41 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%) 
Head discomfort * 1  2/41 (4.88%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Headache * 1  4/41 (9.76%)  4/40 (10.00%)  5/40 (12.50%)  4/39 (10.26%) 
Somnolence * 1  5/41 (12.20%)  1/40 (2.50%)  4/40 (10.00%)  2/39 (5.13%) 
Psychiatric disorders         
Abnormal dreams * 1  0/41 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%) 
Confusional state * 1  0/41 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
Reproductive system and breast disorders         
Ejaculation delayed * 1  1/41 (2.44%)  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
Metrorrhagia * 1  1/41 (2.44%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Vascular disorders         
Haematoma * 1  1/41 (2.44%)  1/40 (2.50%)  1/40 (2.50%)  1/39 (2.56%) 
Hot flush * 1  0/41 (0.00%)  1/40 (2.50%)  2/40 (5.00%)  0/39 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01190514     History of Changes
Other Study ID Numbers: B2061035
First Submitted: August 24, 2010
First Posted: August 27, 2010
Results First Submitted: December 21, 2011
Results First Posted: January 27, 2012
Last Update Posted: January 27, 2012