check_circleStudy Completed
Vasomotor System
Bayer Identifier:
91544
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
ZK283197 for Treatment of Vasomotor Symptoms
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
45 - 65 YearsTrial summary
Enrollment Goal
116Trial Dates
October 2007 - December 2008Phase
Phase 2Could I Receive a placebo
YesProducts
ERß Agonist (BAY86-5310)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | LCG Bioscience Bourn Hall Clinic | Cambridge, CB23 2TN, United Kingdom |
Completed | Dinox GmbH Berlin | Berlin, 10115, Germany |
Completed | Bayer Pharma AG | Berlin, 13353, Germany |
Completed | Dinox B.V. | Groningen, 9713 GZ, Netherlands |
Primary Outcome
- Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phasedate_rangeTime Frame:Between baseline and Week 8 of the treatment phaseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)enhanced_encryptionYesSafety Issue:
- Exposure-response relationshipA 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 283197date_rangeTime Frame:At week 8enhanced_encryptionNoSafety Issue:
- Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushesdate_rangeTime Frame:From baseline up to 8 weeksenhanced_encryptionNoSafety Issue:
- Change from baseline to all treatment weeks in severity and frequency of all hot flushesdate_rangeTime Frame:From baseline up to 8 weeksenhanced_encryptionNoSafety Issue:
- Trough levels at every visitdate_rangeTime Frame:Before 1st administration and at Week 1, 2, 4, 6 and 8enhanced_encryptionNoSafety Issue:
- AUC(0–24h)Area under the curve from administration to 24 h after administrationdate_rangeTime Frame:Pre-dose and up to 24 h post-dose (measured between Week 4-8)enhanced_encryptionNoSafety Issue:
- CmaxMaximum serum concentrationdate_rangeTime Frame:Pre-dose and up to 24 h post-dose (measured between Week 4-8)enhanced_encryptionNoSafety Issue:
- tmaxTime to reach maximum drug concentrationdate_rangeTime Frame:Pre-dose and up to 24 h post-dose (measured between Week 4-8)enhanced_encryptionNoSafety Issue:
- CminMinimum serum concentrationdate_rangeTime Frame:Pre-dose and up to 24 h post-dose (measured between Week 4-8)enhanced_encryptionNoSafety Issue:
- CaveAverage serum concentrationdate_rangeTime Frame:Pre-dose and up to 24 h post-dose (measured between Week 4-8)enhanced_encryptionNoSafety Issue:
- Vaginal cytologyThe epithelial maturation index/value and the karyopycnotic index were assesseddate_rangeTime Frame:Between baseline and Week 8enhanced_encryptionYesSafety Issue:
- Endometrial thicknessTransvaginal ultrasound was performed to demonstrate the absence of relevant endometrium growthdate_rangeTime Frame:Fom baseline to Week 8enhanced_encryptionYesSafety Issue:
- Endometrial histologydate_rangeTime Frame:Between baseline and Week 8enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4Additional Information
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