ZK283197 for Treatment of Vasomotor Symptoms - Tabular View

Tracking Information

First Received Date ^ICMJE

September 28, 2007

Last Updated Date

February 5, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean relative change in frequency of moderate to severe hot flushes per week between baseline (at least 2-week run-in phase) and week 8 of the treatment phase. [ Time Frame: Between baseline and week 8 of the treatment phase ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Mean relative change in frequency of moderate to severe hot flushes per week between baseline (at least 2-week run-in phase) and week 8 of the treatment phase. [ Time Frame: between baseline and week 8 of the treatment phase ]

Change History

Complete list of historical versions of study NCT00537836 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability [ Time Frame: Between baseline until end of Follow-up period ] [ Designated as safety issue: Yes ]
Pharmacodynamics incl. vaginal cytology, endometrial thickness, endometrial histology and exploratory mRNA expression profiling of endometrial biopsies and blood cells [ Time Frame: From baseline to all treatment weeks up to 8 weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: From baseline to all treatment weeks up to 8 weeks ] [ Designated as safety issue: No ]
Exposure - response relationship [ Time Frame: From baseline to all treatment weeks up to 8 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability [ Time Frame: between baseline until end of Follow-up period ]
Pharmacodynamics incl. vaginal cytology, endometrial thickness, endometrial histology and exploratory mRNA expression profiling of endometrial biopsies and blood cells [ Time Frame: from baseline to all treatment weeks up to 8 weeks ]
Pharmacokinetics [ Time Frame: from baseline to all treatment weeks up to 8 weeks ]
Exposure - response relationship [ Time Frame: from baseline to all treatment weeks up to 8 weeks ]

Descriptive Information

Brief Title ^ICMJE

ZK283197 for Treatment of Vasomotor Symptoms

Official Title ^ICMJE

A Double- Blind, Randomized, Placebo and Active Controlled, Multi-Center 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.

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vasomotor System

Intervention ^ICMJE

Drug: BAY86-5310 (ZK283197)
Drug: Placebo
Drug: 17ß-estradiol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

112

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women with at least 35 moderate to severe hot flushes in seven consecutive days
Age: 45 - 65 years (inclusive)
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

Gender

Female

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Netherlands, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00537836

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study ID Numbers ^ICMJE

91544, EudraCT-No.: 2007-001791-36, 310781

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP