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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003522-29 | EudraCT Number | ||
| 309763 | Other Identifier | Company Internal |
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The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | up to 24 weeks of treatment |
| Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected) | 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 24 weeks of treatment |
| Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44) | Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44) | from week 24 to week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Folate Metabolite Pattern in Plasma at Baseline | Folate metabolite pattern in plasma at baseline | pre-treatment |
| Folate Metabolite Pattern in Plasma at Cycle 3 | Folate metabolite pattern in plasma at cycle 3 |
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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 |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | Bavaria | 89231 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23610531 | Result | Diefenbach K, Trummer D, Ebert F, Lissy M, Koch M, Rohde B, Blode H. EE-drospirenone-levomefolate calcium versus EE-drospirenone + folic acid: folate status during 24 weeks of treatment and over 20 weeks following treatment cessation. Int J Womens Health. 2013 Apr 11;5:149-63. doi: 10.2147/IJWH.S37254. Print 2013. |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid | Drug | 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. |
|
| week 12 |
| Folate Metabolite Pattern in Plasma at Cycle 6 | Folate metabolite pattern in plasma at cycle 6 | week 24 |
| Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin | Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin | baseline and week 24 |
| Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid | Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid | baseline, and up to 24 weeks of treatment |
| FG001 | 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. |
| Received Treatment |
|
| Completed Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| 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 | 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) | 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. | Posted | Geometric Mean | 95% Confidence Interval | nmol·week/L | up to 24 weeks of treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected) | 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. | Posted | Geometric Mean | 95% Confidence Interval | nmol·week/L | up to 24 weeks of treatment |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44) | Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44) | Posted | Number | proportion of participants | from week 24 to week 44 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Folate Metabolite Pattern in Plasma at Baseline | Folate metabolite pattern in plasma at baseline | 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 | Mean | Standard Deviation | nmol/L | pre-treatment |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Folate Metabolite Pattern in Plasma at Cycle 3 | Folate metabolite pattern in plasma at cycle 3 | Posted | Mean | Standard Deviation | nmol/L | week 12 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Folate Metabolite Pattern in Plasma at Cycle 6 | Folate metabolite pattern in plasma at cycle 6 | Posted | Mean | Standard Deviation | nmol/L | week 24 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin | Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin | Posted | Mean | Standard Deviation | µmol/L | baseline and week 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid | Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid | Posted | Mean | Standard Deviation | µmol/L | baseline, and up to 24 weeks of treatment |
|
|
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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 0.03 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. | 6 | 86 | 84 | 86 | ||
| EG001 | 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. | 3 | 86 | 84 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine 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 |
| |
| Eye allergy | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Eye pruritus | Eye 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 |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Faeces hard | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Lip blister | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oral pruritus | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Radicular cyst | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hunger | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Puncture site pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes dermatitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vaginal candidiasis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ear canal injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Whiplash injury | Injury, poisoning and procedural complications | MedDRA10.0 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA10.0 | Non-systematic Assessment |
| |
| Electrocardiogram P wave abnormal | Investigations | MedDRA10.0 | Non-systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA10.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA10.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA10.0 | Non-systematic Assessment |
| |
| Food craving | Metabolism and nutrition disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Myosclerosis | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA10.0 | Non-systematic Assessment |
| |
| Breast fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA10.0 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA10.0 | Non-systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Urge incontinence | Renal and urinary disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Breast discomfort | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Menstruation delayed | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Vulval disorder | Reproductive system and breast disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Photosensitivity allergic reaction | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Trichorrhexis | Skin and subcutaneous tissue disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Dental treatment | Surgical and medical procedures | MedDRA10.0 | Non-systematic Assessment |
| |
| Endodontic procedure | Surgical and medical procedures | MedDRA10.0 | Non-systematic Assessment |
| |
| Mole excision | Surgical and medical procedures | MedDRA10.0 | Non-systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | MedDRA10.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA10.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary 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 | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| C035144 | drospirenone |
| C569381 | levomefolate calcium |
| C534342 | drospirenone and ethinyl estradiol combination |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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