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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001791-36 | EudraCT Number | ||
| 310781 | Other Identifier | Company internal |
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The primary goal of the planned study is to investigate the efficacy and safety of ZK 283197 in the dosage of 2 and 3 mg ingested once daily during a period of 8 weeks for the treatment of hot flushes. In order to be able to assess the efficacy of the test substance, this is compared with the efficacy of 1 mg Estradiol and placebo. The comparator Estradiol is a certified hormone preparation, which is already used for the treatment of hot flushes as standard treatment. After passing the screening, volunteers will start with a run-in phase followed by a 8 weeks treatment and a follow-up phase. 112 postmenopausal women with hot flushes and without relevant prior diseases will participate in three European countries (2 study sites in Germany, 1 study site in Great Britain and 1 study site in The Netherlands) in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZK 283197, 3 mg | Experimental | Postmenopausal women with hot flushes received 3 mg (3 x 1 mg tablets) ZK 283197, administered orally once daily over 8 weeks |
|
| Matching placebo | Placebo Comparator | Postmenopausal women with hot flushes received placebo (3 tablets) orally once daily over 8 weeks |
|
| ZK 283197, 2 mg | Experimental | Postmenopausal women with hot flushes received 2 mg (2 x 1 mg tablet) ZK 283197 plus 1 placebo tablet, once daily orally over 8 weeks |
|
| 17ß-estradiol | Active Comparator | Postmenopausal women with hot flushes received 1 mg (2 x 0.5 mg tablet) 17ß-estradiol plus 1 placebo tablet, once daily orally over 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY 86-5310 (ZK 283197) | Drug | 3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phase | Between baseline and Week 8 of the treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | From Week 1 of treatment until end of Follow-up period (approximately 12 weeks) | |
| Exposure-response relationship | A generalized linear model was applied to explore the dependence of the number of hot flushes in Week 8 to (i) the dose of ZK 283197, (ii) the AUC of ZK 283197, (iii) the maximum concentration Cmax of ZK 283197 and (iv) the average concentration Cave of ZK 283197 |
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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 |
|---|---|---|---|---|---|---|
| Berlin | State of Berlin | 10115 | Germany | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Placebo, once daily p.o. over 8 weeks |
|
| 17ß-estradiol | Drug | 1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks |
|
| At week 8 |
| Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushes | From baseline up to 8 weeks |
| Change from baseline to all treatment weeks in severity and frequency of all hot flushes | From baseline up to 8 weeks |
| Trough levels at every visit | Before 1st administration and at Week 1, 2, 4, 6 and 8 |
| AUC(0-24h) | Area under the curve from administration to 24 h after administration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) |
| Cmax | Maximum serum concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) |
| tmax | Time to reach maximum drug concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) |
| Cmin | Minimum serum concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) |
| Cave | Average serum concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) |
| Vaginal cytology | The epithelial maturation index/value and the karyopycnotic index were assessed | Between baseline and Week 8 |
| Endometrial thickness | Transvaginal ultrasound was performed to demonstrate the absence of relevant endometrium growth | Fom baseline to Week 8 |
| Endometrial histology | Between baseline and Week 8 |
| Berlin |
| State of Berlin |
| 13353 |
| Germany |
| Groningen | 9713 GZ | Netherlands |
| Cambridge | Cambridgeshire | CB23 2TN | United Kingdom |