Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01258660
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : May 13, 2011
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Contraception
Interventions Drug: EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo
Drug: EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid
Enrollment 172
Recruitment Details Healthy female volunteers aged 18 – 40 (inclusive), desiring contraception, with Red Blood Cell folate > 317 nmol/L and < 906 nmol/L, with no concomitant intake of vitamin supplements or medication containing folate or interacting with folate, and no vitamin B12 deficiency, were enrolled from 11 December 2006 to 15 January 2008 at 1 German center
Pre-assignment Details 235 female volunteers were screened according to the inclusion and exclusion criteria to determine that the volunteer was in a good state of health and appropriate for inclusion in the study, and 172 volunteers were randomized at one center.
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone. Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Period Title: Overall Study
Started 86 [1] 86 [1]
Received Treatment 79 82
Completed Treatment 79 81
Completed 75 [2] 75 [2]
Not Completed 11 11
Reason Not Completed
Adverse Event             2             4
Withdrawal by Subject             3             0
due to relocation             2             0
Protocol Violation             0             1
Invalid for primary analysis data set             4             6
[1]
randomized and received at least one dose of treatment
[2]
completed and valid for primary analysis data set
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid Total
Hide Arm/Group Description Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone. Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone. Total of all reporting groups
Overall Number of Baseline Participants 86 86 172
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 172 participants
28.4  (5.80) 27.0  (5.49) 27.7  (5.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 172 participants
Female
86
 100.0%
86
 100.0%
172
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected)
Hide Description The Area under the curve (AUC) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Time Frame up to 24 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description:
Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 75 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: nmol·week/L
plasma folate
1030
(975 to 1087)
904
(859 to 951)
RBC folate
24176
(23007 to 25405)
21876
(21011 to 22776)
2.Primary Outcome
Title Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)
Hide Description The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Time Frame up to 24 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description:
Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 75 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: nmol·week/L
plasma folate
640
(600 to 684)
561
(521 to 604)
RBC folate
10427
(9658 to 11258)
8863
(8383 to 9370)
3.Primary Outcome
Title Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
Hide Description Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)
Time Frame from week 24 to week 44
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
Hide Arm/Group Description:
Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: proportion of participants
week 24 0.053
week 26 0.067
week 28 0.147
week 30 0.213
week 32 0.400
week 34 0.533
week 36 0.707
week 38 0.760
week 40 0.827
week 42 0.867
week 44 0.907
4.Secondary Outcome
Title Folate Metabolite Pattern in Plasma at Baseline
Hide Description Folate metabolite pattern in plasma at baseline
Time Frame pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description:
Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 74 75
Mean (Standard Deviation)
Unit of Measure: nmol/L
Tetrahydrofolate (THF) 4.07  (0.357) 4.60  (0.656)
5,10-methenyl-THF 1.57  (0.412) 1.63  (0.372)
5.Secondary Outcome
Title Folate Metabolite Pattern in Plasma at Cycle 3
Hide Description Folate metabolite pattern in plasma at cycle 3
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description:
Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: nmol/L
THF 4.98  (1.851) 5.28  (1.806)
5,10-methenyl-THF 1.76  (0.603) 1.45  (0.282)
6.Secondary Outcome
Title Folate Metabolite Pattern in Plasma at Cycle 6
Hide Description Folate metabolite pattern in plasma at cycle 6
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description:
Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: nmol/L
THF 5.92  (2.318) 5.76  (2.835)
5,10-methenyl-THF 1.46  (0.238) 1.95  (1.166)
7.Secondary Outcome
Title Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin
Hide Description Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
Hide Arm/Group Description:
Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: µmol/L
baseline 9.3  (2.2)
24 weeks 7.5  (1.6)
8.Secondary Outcome
Title Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid
Hide Description Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid
Time Frame baseline, and up to 24 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description:
Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: µmol/L
baseline 9.2  (1.9)
24 weeks 7.6  (1.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Hide Arm/Group Description Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone. Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
All-Cause Mortality
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/86 (6.98%)      3/86 (3.49%)    
Gastrointestinal disorders     
Abdominal pain * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Abdominal pain lower * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Colitis ulcerative * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Diarrhoea * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Nausea * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
General disorders     
Impaired healing * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Infections and infestations     
Appendicitis * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Pyelonephritis * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Injury, poisoning and procedural complications     
Alcohol poisoning * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Foreign body trauma * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acoustic neuroma * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Nervous system disorders     
Loss of consciousness * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Reproductive system and breast disorders     
Haemorrhagic ovarian cyst * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hyperventilation * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   84/86 (97.67%)      84/86 (97.67%)    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Cardiac disorders     
Cardiovascular disorder * 1  3/86 (3.49%)  3 2/86 (2.33%)  2
Tachycardia * 1  2/86 (2.33%)  3 0/86 (0.00%)  0
Ventricular extrasystoles * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Ear and labyrinth disorders     
Ear discomfort * 1  1/86 (1.16%)  1 4/86 (4.65%)  4
Ear pain * 1  0/86 (0.00%)  0 3/86 (3.49%)  3
Tinnitus * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Endocrine disorders     
Basedow's disease * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Hyperthyroidism * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Hypothyroidism * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Eye disorders     
Conjunctivitis * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Dry eye * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Eye allergy * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Eye pruritus * 1  1/86 (1.16%)  1 1/86 (1.16%)  3
Gastrointestinal disorders     
Abdominal distension * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Abdominal pain * 1  3/86 (3.49%)  3 6/86 (6.98%)  9
Abdominal pain lower * 1  1/86 (1.16%)  3 0/86 (0.00%)  0
Abdominal pain upper * 1  5/86 (5.81%)  6 5/86 (5.81%)  6
Aphthous stomatitis * 1  0/86 (0.00%)  0 2/86 (2.33%)  2
Chapped lips * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Cheilitis * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Colitis ulcerative * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Constipation * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Dental caries * 1  0/86 (0.00%)  0 1/86 (1.16%)  2
Diarrhoea * 1  17/86 (19.77%)  21 19/86 (22.09%)  23
Faeces hard * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Flatulence * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Gastritis * 1  1/86 (1.16%)  1 1/86 (1.16%)  1
Gastrointestinal disorder * 1  1/86 (1.16%)  1 1/86 (1.16%)  1
Gastrointestinal hypomotility * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Gastrointestinal pain * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Gingivitis * 1  3/86 (3.49%)  3 1/86 (1.16%)  1
Lip blister * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Nausea * 1  14/86 (16.28%)  17 21/86 (24.42%)  27
Oral mucosal blistering * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Oral pruritus * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Radicular cyst * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Toothache * 1  8/86 (9.30%)  9 5/86 (5.81%)  6
Vomiting * 1  14/86 (16.28%)  14 17/86 (19.77%)  21
General disorders     
Chills * 1  1/86 (1.16%)  1 1/86 (1.16%)  1
Fatigue * 1  3/86 (3.49%)  3 7/86 (8.14%)  7
Hunger * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Impaired healing * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Influenza like illness * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Malaise * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Oedema peripheral * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Puncture site pain * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Pyrexia * 1  10/86 (11.63%)  10 6/86 (6.98%)  6
Hepatobiliary disorders     
Cholelithiasis * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Immune system disorders     
Allergy to animal * 1  2/86 (2.33%)  4 0/86 (0.00%)  0
Seasonal allergy * 1  7/86 (8.14%)  12 9/86 (10.47%)  13
Infections and infestations     
Abscess limb * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Acute tonsillitis * 1  1/86 (1.16%)  1 2/86 (2.33%)  2
Anogenital warts * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Appendicitis * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Bronchitis * 1  3/86 (3.49%)  3 1/86 (1.16%)  2
Cystitis * 1  4/86 (4.65%)  4 5/86 (5.81%)  7
Ear infection * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Gastroenteritis * 1  6/86 (6.98%)  6 8/86 (9.30%)  8
Gastrointestinal infection * 1  4/86 (4.65%)  4 6/86 (6.98%)  6
Herpes dermatitis * 1  1/86 (1.16%)  2 0/86 (0.00%)  0
Herpes ophthalmic * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Herpes virus infection * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Herpes zoster * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Infectious mononucleosis * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Influenza * 1  2/86 (2.33%)  2 0/86 (0.00%)  0
Laryngitis * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Nasopharyngitis * 1  63/86 (73.26%)  106 60/86 (69.77%)  139
Oral herpes * 1  6/86 (6.98%)  7 9/86 (10.47%)  12
Otitis media * 1  0/86 (0.00%)  0 1/86 (1.16%)  2
Pneumonia * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Post procedural infection * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Pyelonephritis * 1  1/86 (1.16%)  1 1/86 (1.16%)  2
Rhinitis * 1  2/86 (2.33%)  2 0/86 (0.00%)  0
Sinusitis * 1  8/86 (9.30%)  10 4/86 (4.65%)  5
Tinea versicolour * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Tonsillitis * 1  3/86 (3.49%)  4 3/86 (3.49%)  3
Tooth infection * 1  2/86 (2.33%)  3 1/86 (1.16%)  1
Vaginal candidiasis * 1  4/86 (4.65%)  5 3/86 (3.49%)  3
Vulvitis * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Vulvovaginal mycotic infection * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Wound infection * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Arthropod bite * 1  3/86 (3.49%)  3 1/86 (1.16%)  1
Arthropod sting * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Concussion * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Contusion * 1  2/86 (2.33%)  2 1/86 (1.16%)  1
Ear canal injury * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Excoriation * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Eye injury * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Foot fracture * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Foreign body trauma * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Hand fracture * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Ligament rupture * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Ligament sprain * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Limb injury * 1  2/86 (2.33%)  3 0/86 (0.00%)  0
Procedural pain * 1  1/86 (1.16%)  1 3/86 (3.49%)  3
Skeletal injury * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Tendon injury * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Thermal burn * 1  0/86 (0.00%)  0 1/86 (1.16%)  1
Traumatic haematoma * 1  1/86 (1.16%)  1 0/86 (0.00%)  0
Whiplash injury * 2  1/86 (1.16%)  1 1/86 (1.16%)  1
Investigations     
Body temperature increased * 2  0/86 (0.00%)  0 1/86 (1.16%)  2
Electrocardiogram P wave abnormal * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Serum ferritin decreased * 2  0/86 (0.00%)  0 2/86 (2.33%)  4
Weight decreased * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Weight increased * 2  1/86 (1.16%)  2 1/86 (1.16%)  1
Metabolism and nutrition disorders     
Food craving * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 2  4/86 (4.65%)  4 4/86 (4.65%)  4
Back pain * 2  5/86 (5.81%)  10 5/86 (5.81%)  5
Coccydynia * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Intervertebral disc protrusion * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Muscle tightness * 2  1/86 (1.16%)  1 1/86 (1.16%)  1
Musculoskeletal pain * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Musculoskeletal stiffness * 2  6/86 (6.98%)  6 2/86 (2.33%)  2
Myalgia * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Myosclerosis * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Neck pain * 2  4/86 (4.65%)  5 0/86 (0.00%)  0
Osteoarthritis * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Pain in extremity * 2  2/86 (2.33%)  2 5/86 (5.81%)  5
Pain in jaw * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Tendonitis * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Tenosynovitis * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acoustic neuroma * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Breast fibroma * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Melanocytic naevus * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Nervous system disorders     
Aphonia * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Cervicobrachial syndrome * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Dizziness * 2  3/86 (3.49%)  3 1/86 (1.16%)  1
Headache * 2  45/86 (52.33%)  122 53/86 (61.63%)  173
Intercostal neuralgia * 2  2/86 (2.33%)  2 0/86 (0.00%)  0
Lethargy * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Loss of consciousness * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Migraine * 2  0/86 (0.00%)  0 1/86 (1.16%)  3
Psychiatric disorders     
Anxiety * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Mood altered * 2  1/86 (1.16%)  2 0/86 (0.00%)  0
Mood swings * 2  2/86 (2.33%)  4 0/86 (0.00%)  0
Sleep disorder * 2  1/86 (1.16%)  2 0/86 (0.00%)  0
Renal and urinary disorders     
Bladder spasm * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Nocturia * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Urge incontinence * 2  1/86 (1.16%)  2 0/86 (0.00%)  0
Reproductive system and breast disorders     
Breast discomfort * 2  2/86 (2.33%)  2 2/86 (2.33%)  2
Breast disorder * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Breast enlargement * 2  0/86 (0.00%)  0 1/86 (1.16%)  2
Breast pain * 2  3/86 (3.49%)  3 0/86 (0.00%)  0
Breast swelling * 2  1/86 (1.16%)  2 0/86 (0.00%)  0
Breast tenderness * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Cervical dysplasia * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Dysmenorrhoea * 2  4/86 (4.65%)  6 7/86 (8.14%)  14
Haemorrhagic ovarian cyst * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Menometrorrhagia * 2  2/86 (2.33%)  2 1/86 (1.16%)  1
Menorrhagia * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Menstruation delayed * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Metrorrhagia * 2  6/86 (6.98%)  10 6/86 (6.98%)  7
Nipple pain * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Ovarian cyst * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Vaginal discharge * 2  2/86 (2.33%)  2 0/86 (0.00%)  0
Vulval disorder * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Cough * 2  20/86 (23.26%)  26 21/86 (24.42%)  26
Dysphonia * 2  1/86 (1.16%)  1 2/86 (2.33%)  2
Hyperventilation * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Nasal congestion * 2  1/86 (1.16%)  1 5/86 (5.81%)  6
Pharyngolaryngeal pain * 2  18/86 (20.93%)  25 24/86 (27.91%)  35
Productive cough * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Skin and subcutaneous tissue disorders     
Acne * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Alopecia * 2  3/86 (3.49%)  3 1/86 (1.16%)  2
Dermatitis acneiform * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Dermatitis allergic * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Dry skin * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Onychoclasis * 2  1/86 (1.16%)  2 0/86 (0.00%)  0
Photosensitivity allergic reaction * 2  3/86 (3.49%)  4 0/86 (0.00%)  0
Pityriasis rosea * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Rash * 2  2/86 (2.33%)  3 2/86 (2.33%)  2
Rash erythematous * 2  2/86 (2.33%)  2 0/86 (0.00%)  0
Rash pruritic * 2  1/86 (1.16%)  1 1/86 (1.16%)  1
Skin disorder * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Trichorrhexis * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Surgical and medical procedures     
Dental treatment * 2  3/86 (3.49%)  3 0/86 (0.00%)  0
Endodontic procedure * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
Mole excision * 2  0/86 (0.00%)  0 1/86 (1.16%)  1
Wisdom teeth removal * 2  1/86 (1.16%)  1 1/86 (1.16%)  1
Vascular disorders     
Circulatory collapse * 2  1/86 (1.16%)  1 1/86 (1.16%)  1
Haematoma * 2  1/86 (1.16%)  1 2/86 (2.33%)  3
Hypotension * 2  1/86 (1.16%)  1 0/86 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA10.0
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.
PI (principal investigator) of CRO (contract research organization) will refrain from publishing any data or information generated or derived as a result of the performance of the Services.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01258660     History of Changes
Other Study ID Numbers: 91509
2006-003522-29 ( EudraCT Number )
309763 ( Other Identifier: Company Internal )
First Submitted: December 10, 2010
First Posted: December 13, 2010
Results First Submitted: April 19, 2011
Results First Posted: May 13, 2011
Last Update Posted: September 20, 2013