Official Title: “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.”

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.

Study Type: Interventional

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

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: ZK 283197
  • 3 mg ZK 283197, once daily p.o. over 8 weeks (n = 36)
• Drug: Placebo
  • Placebo, once daily p.o. over 8 weeks (n = 36)
• Drug: ZK 283197
  • 2 mg ZK 283197, once daily p.o. over 8 weeks (n = 20)
• Drug: 17ß-estradiol
  • 1 mg 17ß-estradiol, once daily p.o. over 8 weeks (n = 20)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2
• Experimental: Arm 3
• Active Comparator: Arm 4

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Safety and tolerability
  • Time Frame: between baseline until end of Follow-up period
    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
    Safety Issue?: Yes
• Pharmacokinetics
  • Time Frame: from baseline to all treatment weeks up to 8 weeks
    Safety Issue?: No
• Exposure - response relationship
  • Time Frame: from baseline to all treatment weeks up to 8 weeks
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Clinical Trials Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00537836

Study ID Number: 91544

ClinicalTrials.gov Identifier: NCT00537836

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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