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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006199-39 | EudraCT Number | ||
| 310523 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Laboratorium für Klinische Forschung | UNKNOWN |
| Diagnostic Cytology Laboratory | UNKNOWN |
| University of California, San Francisco | OTHER |
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The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25mg DRSP / 0.5mg E2 (BAY86-4891) | Experimental | One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle). |
|
| 0.5mg NETA / 1.0mg E2 (Activella) | Active Comparator | One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25mg DRSP / 0.5mg E2 (BAY86-4891) | Drug | One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment) | The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only. | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Amenorrhea During Month 1 to 3 of Treatment | The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval. | Month 1 to Month 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 |
|---|---|---|---|---|---|---|
| Chandler | Arizona | 85224 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23531117 | Result | Genazzani AR, Schmelter T, Schaefers M, Gerlinger C, Gude K. One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17beta-estradiol in postmenopausal women. Climacteric. 2013 Aug;16(4):490-8. doi: 10.3109/13697137.2013.783797. Epub 2013 May 11. |
| Label | URL |
|---|---|
| click here and search for Bayer Product information provided by the EMA | View source |
Not provided
944 women screened, 661 treated. 282 failed screening: consent withdrawn (55), in-/exclusion criteria not met (209), lost to follow-up (3), other (15). 1 woman was randomized but not treated (own decision). 5 women completed the study but not study medication, i.e. they stopped medication early but remained in the study for final assessments.
Only non-hysterectomized, postmenopausal women could take part in this study. The women had to have symptoms requiring hormone therapy in the opinion of the investigator. An endometrial biopsy at screening was to show no evidence of endometrial hyperplasia or cancer.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.25mg DRSP / 0.5mg E2 (BAY86-4891) | One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle). |
| FG001 | 0.5mg NETA / 1.0mg E2 (Activella) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 0.5mg NETA / 1.0mg E2 (Activella) | Drug | One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle). |
|
| Number of Participants With Amenorrhea During Month 10 to 12 of Treatment | The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval. | Month 10 to Month 12 |
| San Diego |
| California |
| 92103 |
| United States |
| San Diego | California | 92108 | United States |
| Denver | Colorado | 80218 | United States |
| Greenwood Village | Colorado | 80111 | United States |
| Boynton Beach | Florida | 33437 | United States |
| Clearwater | Florida | 33759 | United States |
| Boise | Idaho | 83704 | United States |
| Amite | Louisiana | 70422 | United States |
| Marrero | Louisiana | 70072 | United States |
| Las Vegas | Nevada | 89122 | United States |
| Cleveland | Ohio | 44122 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Columbia | South Carolina | 29201 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Richmond | Virginia | 23294 | United States |
| Seattle | Washington | 98105 | United States |
| Lanús Oeste | Buenos Aires | 1824 | Argentina |
| San Isidro | Buenos Aires | B1642CLN | Argentina |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1117ABH | Argentina |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1280AEB | Argentina |
| Mödling | Lower Austria | 2340 | Austria |
| Wiener Neustadt | Lower Austria | 2700 | Austria |
| Fürstenfeld | Styria | 8280 | Austria |
| Wörgl | Tyrol | 6300 | Austria |
| Bregenz | Vorarlberg | 6900 | Austria |
| Innsbruck | 6020 | Austria |
| Klagenfurt | 9020 | Austria |
| Mürzzuschlag | 8680 | Austria |
| Sankt Pölten | 3100 | Austria |
| Vienna | 1030 | Austria |
| Vienna | 1060 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1200 | Austria |
| Zeltweg | 8740 | Austria |
| Goiânia | Goiás | 74175-080 | Brazil |
| Curitiba | Paraná | 80030-220 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| São Paulo | São Paulo | 04062-003 | Brazil |
| Aalborg | 9000 | Denmark |
| Ballerup Municipality | 2750 | Denmark |
| Vejle | 7100 | Denmark |
| Bologna | 40138 | Italy |
| Cagliari | 09124 | Italy |
| Modena | 41124 | Italy |
| Novara | 28100 | Italy |
| Parma | 43100 | Italy |
| Pisa | 56126 | Italy |
| Sassari | 07100 | Italy |
| Siena | 53100 | Italy |
| Mexico City | Mexico City | Mexico |
| México | 06700 | Mexico |
| México, D.F. | 14050 | Mexico |
| Monterrey | 64460 | Mexico |
| Moscow | 117415 | Russia |
| Moscow | 177997 | Russia |
| Moskva | 101000 | Russia |
| Moskva | 113093 | Russia |
| Moskva | 117997 | Russia |
One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.25mg DRSP / 0.5mg E2 (BAY86-4891) | One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle). |
| BG001 | 0.5mg NETA / 1.0mg E2 (Activella) | One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle). |
| 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 |
| ||||||||||||||||
| Body Mass Index (BMI) | Body mass index was calculated with body weight and height measured at screening (BMI = body weight in kg/ body height in m^2). | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Number of participants with hysterectomy/oophorectomy | Number | Participants |
| ||||||||||||||||
| Years since last menstruation at baseline | Mean | Standard Deviation | years |
|
| 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 | Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment) | The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only. | For the DRSP/E2 group only - Primary analysis set (PAS): All subjects from the full analysis set (FAS) who either had a biopsy result classified as 'normal' or 'hyperplasia or worse' after a year of treatment or who prematurely discontinued the study before Cycle 13 with a biopsy classified as 'hyperplasia or worse'. | Posted | Number | Participants | Up to one year |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Amenorrhea During Month 1 to 3 of Treatment | The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval. | Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations | Posted | Number | Participants | Month 1 to Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Amenorrhea During Month 10 to 12 of Treatment | The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval. | Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations | Posted | Number | Participants | Month 10 to Month 12 |
|
|
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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 | 0.25mg DRSP / 0.5mg E2 (BAY86-4891) | One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle). | 16 | 489 | 172 | 489 | ||
| EG001 | 0.5mg NETA / 1.0mg E2 (Activella) | One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle). | 6 | 172 | 63 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Retinal vascular thrombosis | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Self-injurious ideation | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 12.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer HealthCare AG | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| C035144 | drospirenone |
| C418365 | estradiol, norethindrone drug combination |
Not provided
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| Male |
|
| Oophorectomized |
|
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|
|
|