Trial Condition(s):
Vasomotor System
ZK283197 for Treatment of Vasomotor Symptoms
Bayer Identifier:
91544
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Women with at least 35 moderate to severe hot flushes in seven consecutive days - Body mass index (BMI) : 20 - 30 kg/m² (inclusive) - Postmenopausal status
Exclusion Criteria
- Contraindication for use for hormonal therapy - Prior hysterectomy - Hormonal therapy or intrauterine hormone releasing device within 4 weeks prior to study entry or any long-acting injectable or implant up to 6 months prior to study entry - Repeated intake of medications affecting study aim
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations LCG Bioscience Bourn Hall Clinic Cambridge, United Kingdom, CB23 2TN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Pharma AG Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dinox B.V. Groningen, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A double-blind, randomized, placebo and active controlled, multicenter study to investigate efficacy and safety after oral administration of 2 and 3 mg ZK 283197, 1 mg 17ß-estradiol and placebo once daily for 8 weeks in postmenopausal women with hot flushes
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phaseTimeframe: Between baseline and Week 8 of the treatment phase
Secondary Outcome
- Number of participants with adverse eventsTimeframe: From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)
- 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 283197Timeframe: At week 8
- Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushesTimeframe: From baseline up to 8 weeks
- Change from baseline to all treatment weeks in severity and frequency of all hot flushesTimeframe: From baseline up to 8 weeks
- Trough levels at every visitTimeframe: 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 administrationTimeframe: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
- CmaxMaximum serum concentrationTimeframe: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
- tmaxTime to reach maximum drug concentrationTimeframe: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
- CminMinimum serum concentrationTimeframe: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
- CaveAverage serum concentrationTimeframe: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
- Vaginal cytologyThe epithelial maturation index/value and the karyopycnotic index were assessedTimeframe: Between baseline and Week 8
- Endometrial thicknessTransvaginal ultrasound was performed to demonstrate the absence of relevant endometrium growthTimeframe: Fom baseline to Week 8
- Endometrial histologyTimeframe: Between baseline and Week 8
Additional Information
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