check_circleStudy Completed

Vasomotor System

Bayer Identifier:

91544

ClinicalTrials.gov Identifier:

NCT00537836

EudraCT Number:

2007-001791-36

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

Female

Age

45 - 65 Years

  • - 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

  • - 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
116
Trial Dates
October 2007 - December 2008
Phase
Phase 2
Could I Receive a placebo
Yes
Products
ERß Agonist (BAY86-5310)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
LCG Bioscience Bourn Hall ClinicCambridge, CB23 2TN, United Kingdom
Completed
Dinox GmbH BerlinBerlin, 10115, Germany
Completed
Bayer Pharma AGBerlin, 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 phase
    date_rangeTime Frame:
    Between baseline and Week 8 of the treatment phase
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)
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    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    At week 8
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    Safety Issue:
    No
  • Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushes
    date_rangeTime Frame:
    From baseline up to 8 weeks
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    Safety Issue:
    No
  • Change from baseline to all treatment weeks in severity and frequency of all hot flushes
    date_rangeTime Frame:
    From baseline up to 8 weeks
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    Safety Issue:
    No
  • Trough levels at every visit
    date_rangeTime Frame:
    Before 1st administration and at Week 1, 2, 4, 6 and 8
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    Safety Issue:
    No
  • AUC(0–24h)
    Area under the curve from administration to 24 h after administration
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose (measured between Week 4-8)
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    Safety Issue:
    No
  • Cmax
    Maximum serum concentration
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose (measured between Week 4-8)
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    Safety Issue:
    No
  • tmax
    Time to reach maximum drug concentration
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose (measured between Week 4-8)
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    Safety Issue:
    No
  • Cmin
    Minimum serum concentration
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose (measured between Week 4-8)
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    Safety Issue:
    No
  • Cave
    Average serum concentration
    date_rangeTime Frame:
    Pre-dose and up to 24 h post-dose (measured between Week 4-8)
    enhanced_encryption
    Safety Issue:
    No
  • Vaginal cytology
    The epithelial maturation index/value and the karyopycnotic index were assessed
    date_rangeTime Frame:
    Between baseline and Week 8
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    Safety Issue:
    Yes
  • Endometrial thickness
    Transvaginal ultrasound was performed to demonstrate the absence of relevant endometrium growth
    date_rangeTime Frame:
    Fom baseline to Week 8
    enhanced_encryption
    Safety Issue:
    Yes
  • Endometrial histology
    date_rangeTime Frame:
    Between baseline and Week 8
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    Safety Issue:
    Yes

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

Additional Information

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