ZK283197 for Treatment of Vasomotor Symptoms
Information source: Bayer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vasomotor System
Intervention: ZK 283197 (Drug); Placebo (Drug); ZK 283197 (Drug); 17ß-estradiol (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Safety and tolerabilityPharmacodynamics incl. vaginal cytology, endometrial thickness, endometrial histology and exploratory mRNA expression profiling of endometrial biopsies and blood cells Pharmacokinetics Exposure - response relationship
Eligibility
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Groningen 9713 GZ, Netherlands; Recruiting
Berlin, Berlin / 285 13342, Germany; Recruiting
Berlin, Berlin / 285 10115, Germany; Recruiting
Cambridge, Cambridgeshire CB23 2TN, United Kingdom; Recruiting
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: October 2007
Ending date: January 2009
Last updated: October 30, 2008
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