Trial Outcomes & Findings for 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 (NCT NCT01258660)
NCT ID: NCT01258660
Last Updated: 2013-09-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
172 participants
Primary outcome timeframe
up to 24 weeks of treatment
Results posted on
2013-09-20
Participant Flow
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
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.
Participant milestones
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
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 Study
STARTED
|
86
|
86
|
|
Overall Study
Received Treatment
|
79
|
82
|
|
Overall Study
Completed Treatment
|
79
|
81
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
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 Study
Adverse Event
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
due to relocation
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Invalid for primary analysis data set
|
4
|
6
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=86 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=86 Participants
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
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
28.4 years
STANDARD_DEVIATION 5.80 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 5.49 • n=7 Participants
|
27.7 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeks of treatmentThe 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.
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=75 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=75 Participants
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.
|
|---|---|---|
|
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)
plasma folate
|
1030 nmol·week/L
Interval 975.0 to 1087.0
|
904 nmol·week/L
Interval 859.0 to 951.0
|
|
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)
RBC folate
|
24176 nmol·week/L
Interval 23007.0 to 25405.0
|
21876 nmol·week/L
Interval 21011.0 to 22776.0
|
PRIMARY outcome
Timeframe: up to 24 weeks of treatmentThe 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.
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=75 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=75 Participants
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.
|
|---|---|---|
|
Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)
plasma folate
|
640 nmol·week/L
Interval 600.0 to 684.0
|
561 nmol·week/L
Interval 521.0 to 604.0
|
|
Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)
RBC folate
|
10427 nmol·week/L
Interval 9658.0 to 11258.0
|
8863 nmol·week/L
Interval 8383.0 to 9370.0
|
PRIMARY outcome
Timeframe: from week 24 to week 44Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=75 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
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.
|
|---|---|---|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 24
|
0.053 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 26
|
0.067 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 28
|
0.147 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 30
|
0.213 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 32
|
0.400 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 34
|
0.533 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 36
|
0.707 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 38
|
0.760 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 40
|
0.827 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 42
|
0.867 proportion of participants
|
—
|
|
Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
week 44
|
0.907 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: pre-treatmentPopulation: Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.
Folate metabolite pattern in plasma at baseline
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=74 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=75 Participants
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.
|
|---|---|---|
|
Folate Metabolite Pattern in Plasma at Baseline
Tetrahydrofolate (THF)
|
4.07 nmol/L
Standard Deviation 0.357
|
4.60 nmol/L
Standard Deviation 0.656
|
|
Folate Metabolite Pattern in Plasma at Baseline
5,10-methenyl-THF
|
1.57 nmol/L
Standard Deviation 0.412
|
1.63 nmol/L
Standard Deviation 0.372
|
SECONDARY outcome
Timeframe: week 12Folate metabolite pattern in plasma at cycle 3
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=75 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=75 Participants
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.
|
|---|---|---|
|
Folate Metabolite Pattern in Plasma at Cycle 3
THF
|
4.98 nmol/L
Standard Deviation 1.851
|
5.28 nmol/L
Standard Deviation 1.806
|
|
Folate Metabolite Pattern in Plasma at Cycle 3
5,10-methenyl-THF
|
1.76 nmol/L
Standard Deviation 0.603
|
1.45 nmol/L
Standard Deviation 0.282
|
SECONDARY outcome
Timeframe: week 24Folate metabolite pattern in plasma at cycle 6
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=75 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=75 Participants
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.
|
|---|---|---|
|
Folate Metabolite Pattern in Plasma at Cycle 6
THF
|
5.92 nmol/L
Standard Deviation 2.318
|
5.76 nmol/L
Standard Deviation 2.835
|
|
Folate Metabolite Pattern in Plasma at Cycle 6
5,10-methenyl-THF
|
1.46 nmol/L
Standard Deviation 0.238
|
1.95 nmol/L
Standard Deviation 1.166
|
SECONDARY outcome
Timeframe: baseline and week 24Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=75 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
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.
|
|---|---|---|
|
Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin
baseline
|
9.3 µmol/L
Standard Deviation 2.2
|
—
|
|
Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin
24 weeks
|
7.5 µmol/L
Standard Deviation 1.6
|
—
|
SECONDARY outcome
Timeframe: baseline, and up to 24 weeks of treatmentHomocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid
Outcome measures
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=75 Participants
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
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.
|
|---|---|---|
|
Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid
baseline
|
9.2 µmol/L
Standard Deviation 1.9
|
—
|
|
Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid
24 weeks
|
7.6 µmol/L
Standard Deviation 1.4
|
—
|
Adverse Events
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
Serious events: 6 serious events
Other events: 84 other events
Deaths: 0 deaths
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
Serious events: 3 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=86 participants at risk
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=86 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
General disorders
Impaired healing
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Appendicitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
Other adverse events
| Measure |
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo
n=86 participants at risk
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.
|
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid
n=86 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Anogenital warts
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Nervous system disorders
Dizziness
|
3.5%
3/86 • Number of events 3
|
1.2%
1/86 • Number of events 1
|
|
Nervous system disorders
Headache
|
52.3%
45/86 • Number of events 122
|
61.6%
53/86 • Number of events 173
|
|
Nervous system disorders
Intercostal neuralgia
|
2.3%
2/86 • Number of events 2
|
0.00%
0/86
|
|
Nervous system disorders
Lethargy
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/86
|
1.2%
1/86 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Psychiatric disorders
Mood altered
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Psychiatric disorders
Mood swings
|
2.3%
2/86 • Number of events 4
|
0.00%
0/86
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Renal and urinary disorders
Bladder spasm
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Renal and urinary disorders
Nocturia
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Renal and urinary disorders
Urge incontinence
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Infections and infestations
Bronchitis
|
3.5%
3/86 • Number of events 3
|
1.2%
1/86 • Number of events 2
|
|
Infections and infestations
Cystitis
|
4.7%
4/86 • Number of events 4
|
5.8%
5/86 • Number of events 7
|
|
Reproductive system and breast disorders
Breast discomfort
|
2.3%
2/86 • Number of events 2
|
2.3%
2/86 • Number of events 2
|
|
Infections and infestations
Ear infection
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Gastroenteritis
|
7.0%
6/86 • Number of events 6
|
9.3%
8/86 • Number of events 8
|
|
Infections and infestations
Gastrointestinal infection
|
4.7%
4/86 • Number of events 4
|
7.0%
6/86 • Number of events 6
|
|
Infections and infestations
Herpes dermatitis
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Infections and infestations
Herpes ophthalmic
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Herpes virus infection
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Influenza
|
2.3%
2/86 • Number of events 2
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Breast disorder
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/86
|
1.2%
1/86 • Number of events 2
|
|
Reproductive system and breast disorders
Breast pain
|
3.5%
3/86 • Number of events 3
|
0.00%
0/86
|
|
Infections and infestations
Laryngitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Nasopharyngitis
|
73.3%
63/86 • Number of events 106
|
69.8%
60/86 • Number of events 139
|
|
Infections and infestations
Oral herpes
|
7.0%
6/86 • Number of events 7
|
10.5%
9/86 • Number of events 12
|
|
Infections and infestations
Otitis media
|
0.00%
0/86
|
1.2%
1/86 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Post procedural infection
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
2.3%
2/86 • Number of events 2
|
0.00%
0/86
|
|
Infections and infestations
Sinusitis
|
9.3%
8/86 • Number of events 10
|
4.7%
4/86 • Number of events 5
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
3.5%
3/86 • Number of events 4
|
3.5%
3/86 • Number of events 3
|
|
Infections and infestations
Tooth infection
|
2.3%
2/86 • Number of events 3
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Vaginal candidiasis
|
4.7%
4/86 • Number of events 5
|
3.5%
3/86 • Number of events 3
|
|
Infections and infestations
Vulvitis
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Wound infection
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.5%
3/86 • Number of events 3
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
2/86 • Number of events 2
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ear canal injury
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.3%
2/86 • Number of events 3
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.2%
1/86 • Number of events 1
|
3.5%
3/86 • Number of events 3
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Investigations
Body temperature increased
|
0.00%
0/86
|
1.2%
1/86 • Number of events 2
|
|
Investigations
Electrocardiogram P wave abnormal
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/86
|
2.3%
2/86 • Number of events 4
|
|
Investigations
Weight decreased
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Investigations
Weight increased
|
1.2%
1/86 • Number of events 2
|
1.2%
1/86 • Number of events 1
|
|
Metabolism and nutrition disorders
Food craving
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
4/86 • Number of events 4
|
4.7%
4/86 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
5/86 • Number of events 10
|
5.8%
5/86 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.0%
6/86 • Number of events 6
|
2.3%
2/86 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.7%
4/86 • Number of events 5
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
2/86 • Number of events 2
|
5.8%
5/86 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast fibroma
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Nervous system disorders
Aphonia
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Reproductive system and breast disorders
Breast swelling
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.7%
4/86 • Number of events 6
|
8.1%
7/86 • Number of events 14
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
2.3%
2/86 • Number of events 2
|
1.2%
1/86 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Abscess limb
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Infections and infestations
Acute tonsillitis
|
1.2%
1/86 • Number of events 1
|
2.3%
2/86 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Cardiac disorders
Cardiovascular disorder
|
3.5%
3/86 • Number of events 3
|
2.3%
2/86 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
2.3%
2/86 • Number of events 3
|
0.00%
0/86
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.2%
1/86 • Number of events 1
|
4.7%
4/86 • Number of events 4
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/86
|
3.5%
3/86 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Eye disorders
Conjunctivitis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Eye disorders
Dry eye
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Eye disorders
Eye allergy
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
3/86 • Number of events 3
|
7.0%
6/86 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.2%
1/86 • Number of events 3
|
0.00%
0/86
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
5/86 • Number of events 6
|
5.8%
5/86 • Number of events 6
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/86
|
2.3%
2/86 • Number of events 2
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/86
|
1.2%
1/86 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
19.8%
17/86 • Number of events 21
|
22.1%
19/86 • Number of events 23
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
3.5%
3/86 • Number of events 3
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
16.3%
14/86 • Number of events 17
|
24.4%
21/86 • Number of events 27
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Oral pruritus
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Gastrointestinal disorders
Radicular cyst
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Gastrointestinal disorders
Toothache
|
9.3%
8/86 • Number of events 9
|
5.8%
5/86 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
16.3%
14/86 • Number of events 14
|
19.8%
17/86 • Number of events 21
|
|
General disorders
Chills
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
General disorders
Fatigue
|
3.5%
3/86 • Number of events 3
|
8.1%
7/86 • Number of events 7
|
|
General disorders
Hunger
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
General disorders
Impaired healing
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
General disorders
Influenza like illness
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
General disorders
Malaise
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
General disorders
Oedema peripheral
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
General disorders
Puncture site pain
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
General disorders
Pyrexia
|
11.6%
10/86 • Number of events 10
|
7.0%
6/86 • Number of events 6
|
|
Immune system disorders
Allergy to animal
|
2.3%
2/86 • Number of events 4
|
0.00%
0/86
|
|
Immune system disorders
Seasonal allergy
|
8.1%
7/86 • Number of events 12
|
10.5%
9/86 • Number of events 13
|
|
Reproductive system and breast disorders
Metrorrhagia
|
7.0%
6/86 • Number of events 10
|
7.0%
6/86 • Number of events 7
|
|
Reproductive system and breast disorders
Nipple pain
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.3%
2/86 • Number of events 2
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
20/86 • Number of events 26
|
24.4%
21/86 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.2%
1/86 • Number of events 1
|
2.3%
2/86 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
1/86 • Number of events 1
|
5.8%
5/86 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
20.9%
18/86 • Number of events 25
|
27.9%
24/86 • Number of events 35
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
3/86 • Number of events 3
|
1.2%
1/86 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.2%
1/86 • Number of events 2
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Photosensitivity allergic reaction
|
3.5%
3/86 • Number of events 4
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
2/86 • Number of events 3
|
2.3%
2/86 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.3%
2/86 • Number of events 2
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Trichorrhexis
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Surgical and medical procedures
Dental treatment
|
3.5%
3/86 • Number of events 3
|
0.00%
0/86
|
|
Surgical and medical procedures
Endodontic procedure
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Surgical and medical procedures
Mole excision
|
0.00%
0/86
|
1.2%
1/86 • Number of events 1
|
|
Surgical and medical procedures
Wisdom teeth removal
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
1.2%
1/86 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Vascular disorders
Haematoma
|
1.2%
1/86 • Number of events 1
|
2.3%
2/86 • Number of events 3
|
|
Vascular disorders
Hypotension
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/86 • Number of events 1
|
0.00%
0/86
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER