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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003049-15 | EudraCT Number | ||
| 309664 | Other Identifier | Company Internal |
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The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not using hormonal contraception
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) | Experimental | single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) |
|
| EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca) | Experimental | single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) |
|
| L-5-MTHF Ca 0.451 mg (Metafolin) | Experimental | single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) | Drug | Treatment group A: Single 1 film-coated tablet (Ethinylestradiol [EE] 0.02mg / Drospirenone [DRSP] 3mg) taken orally under fasting condition at intervals of at least one menstrual cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation | Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample | up to 96 hours after administration |
| Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation | 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 | up to 96 hours after administration |
| Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation | Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample | up to 168 hours after administration |
| Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of DRSP Incl. Bioequivalence (BE) Evaluation | 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 | up to 168 hours after administration |
| Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation | The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Concentration (Tmax) of EE | Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content | up to 96 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dinox B.V. | Groningen | 9713GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22067789 | Result | Blode H, Klipping C, Richard F, Trummer D, Rohde B, Diefenbach K. Bioequivalence study of an oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium relative to ethinylestradiol/drospirenone and to levomefolate calcium alone. Contraception. 2012 Feb;85(2):177-84. doi: 10.1016/j.contraception.2011.05.015. Epub 2011 Jul 19. |
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77 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 44 volunteers were randomized at one center.
Healthy young women, aged 18 - 38 years inclusive, who were nonsmokers were enrolled from 20 October 2006 to 13 September 2007 at one center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence A: YAZ, EE20/DRSP/L-5-MTHF Ca, Metafolin | YAZ for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca) | Drug | Treatment group B: Single 1 film-coated tablet (Ethinylestradiol [EE] 0.02mg / Drospirenone [DRSP] 3mg / L-5-methyltetrahydrofolate [L-5-MTHF] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle. |
|
| L-5-MTHF 0.451mg (Metafolin) | Drug | Treatment group C: Single 1 coated tablet (L-5-methyltetrahydrofolate [L-5-MTHF] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle. |
|
| up to 12 hours after administration |
| Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation | The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration. | up to 12 hours after administration |
| Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation | The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample. | up to 12 hours after administration |
| Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation | The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample. | up to 12 hours after administration |
| Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP |
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 |
| up to 72 hours after administration |
| Time to Reach Maximum Concentration (Tmax) of DRSP | Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content | up to 168 hours after administration |
| Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF | Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content | up to 12 hours after administration |
| FG001 | Treatment Sequence B: YAZ, Metafolin, EE20/DRSP/L-5-MTHF Ca | YAZ for Period 1; Metafolin for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]). |
| FG002 | Treatment Sequence C: EE20/DRSP/L-5-MTHF Ca, YAZ, Metafolin | EE20/DRSP/L-5-MTHF Ca for Period 1; YAZ for Period 2; Metafolin for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]). |
| FG003 | Treatment Sequence D: EE20/DRSP/L-5-MTHF Ca, Metafolin, YAZ | EE20/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; YAZ for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP). |
| FG004 | Treatment Sequence E: Metafolin, YAZ, EE20/DRSP/L-5-MTHF Ca | Metafolin for Period 1; YAZ for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]). |
| FG005 | Treatment Sequence F: Metafolin, EE20/DRSP/L-5-MTHF Ca, YAZ | Metafolin for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; YAZ for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP). |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all participants treated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation | Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | up to 96 hours after administration |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation | 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 | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | pg·h/mL | up to 96 hours after administration |
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| Primary | Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation | Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | up to 168 hours after administration |
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| Primary | Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of DRSP Incl. Bioequivalence (BE) Evaluation | 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 | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | ng·h/mL | up to 168 hours after administration |
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| Primary | Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation | The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration. | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | up to 12 hours after administration |
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| Primary | Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation | The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration. | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | nmol·h/L | up to 12 hours after administration |
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| Primary | Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation | The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample. | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | up to 12 hours after administration |
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| Primary | Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation | The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample. | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | nmol·h/L | up to 12 hours after administration |
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| Secondary | Time to Reach Maximum Concentration (Tmax) of EE | Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Median | Full Range | hours | up to 96 hours after administration |
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| Secondary | Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP | 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 | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Geometric Mean | 95% Confidence Interval | ng·h/mL | up to 72 hours after administration |
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| Secondary | Time to Reach Maximum Concentration (Tmax) of DRSP | Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Median | Full Range | hours | up to 168 hours after administration |
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| Secondary | Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF | Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content | Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers. | Posted | Median | Full Range | hours | up to 12 hours after administration |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) | single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) | 0 | 43 | 37 | 43 | ||
| EG001 | EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca) | single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) | 0 | 41 | 30 | 41 | ||
| EG002 | L-5-MTHF Ca 0.451 mg (Metafolin) | single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) | 0 | 43 | 34 | 43 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Eyelid irritation | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Orthostatic intolerance | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Peripheral coldness | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Puncture site pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Dental treatment | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer HealthCare AG | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| C035144 | drospirenone |
| C534342 | drospirenone and ethinyl estradiol combination |
| C005984 | 5-methyltetrahydrofolate |
| C569381 | levomefolate calcium |
Not provided
Not provided
Not provided
| difficulty with blood sampling |
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| non-compliance |
|
A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.
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