NCT00537836

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

September 28, 2007

Last Update Submit

April 8, 2015

Conditions

Vasomotor System

Keywords

Hot flushesTherapy of hot flushes17ß-estradiol (E2)Hormone replacement therapy

Outcome Measures

Primary Outcomes (1)

  • Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phase

    Between baseline and Week 8 of the treatment phase

Secondary Outcomes (13)

  • Number of participants with adverse events

    From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)

  • Exposure-response relationship

    At week 8

  • Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushes

    From baseline up to 8 weeks

  • Change from baseline to all treatment weeks in severity and frequency of all hot flushes

    From baseline up to 8 weeks

  • Trough levels at every visit

    Before 1st administration and at Week 1, 2, 4, 6 and 8

  • +8 more secondary outcomes

Study Arms (4)

ZK 283197, 3 mg

EXPERIMENTAL

Postmenopausal women with hot flushes received 3 mg (3 x 1 mg tablets) ZK 283197, administered orally once daily over 8 weeks

Drug: BAY 86-5310 (ZK 283197)

Matching placebo

PLACEBO COMPARATOR

Postmenopausal women with hot flushes received placebo (3 tablets) orally once daily over 8 weeks

Drug: Placebo

ZK 283197, 2 mg

EXPERIMENTAL

Postmenopausal women with hot flushes received 2 mg (2 x 1 mg tablet) ZK 283197 plus 1 placebo tablet, once daily orally over 8 weeks

Drug: BAY 86-5310 (ZK 283197)

17ß-estradiol

ACTIVE COMPARATOR

Postmenopausal women with hot flushes received 1 mg (2 x 0.5 mg tablet) 17ß-estradiol plus 1 placebo tablet, once daily orally over 8 weeks

Drug: 17ß-estradiol

Interventions

BAY 86-5310 (ZK 283197)DRUG

3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks

ZK 283197, 2 mgZK 283197, 3 mg
PlaceboDRUG

Placebo, once daily p.o. over 8 weeks

Matching placebo
17ß-estradiolDRUG

1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks

17ß-estradiol

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Groningen, 9713 GZ, Netherlands

Location

Unknown Facility

Cambridge, Cambridgeshire, CB23 2TN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 1, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

NL(1)GB(1)DE(2)