Trial Condition(s):

Vasomotor System

ZK283197 for Treatment of Vasomotor Symptoms

Bayer Identifier:

91544

ClinicalTrials.gov Identifier:

NCT00537836

EudraCT Number:

2007-001791-36

Study Completed

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
116
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
ERß Agonist (BAY86-5310)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

LCG Bioscience Bourn Hall Clinic

Cambridge, United Kingdom, CB23 2TN

Status
Completed
 
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Completed
 
Locations

Bayer Pharma AG

Berlin, Germany, 13353

Status
Completed
 
Locations

Dinox B.V.

Groningen, Netherlands, 9713 GZ

Status
Completed
 

Trial Design