ZK283197 for Treatment of Vasomotor Symptoms - Full Text View

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.

Condition	Intervention	Phase
Vasomotor System	Drug: BAY86-5310 (ZK283197) Drug: Placebo Drug: 17ß-estradiol	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	112
Study Start Date:	October 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: BAY86-5310 (ZK283197) 3 mg ZK 283197, once daily p.o. over 8 weeks (n = 36)
Placebo Comparator: Arm 2	Drug: Placebo Placebo, once daily p.o. over 8 weeks (n = 36)
Experimental: Arm 3	Drug: BAY86-5310 (ZK283197) 2 mg ZK 283197, once daily p.o. over 8 weeks (n = 20)
Active Comparator: Arm 4	Drug: 17ß-estradiol 1 mg 17ß-estradiol, once daily p.o. over 8 weeks (n = 20)

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537836

Locations

Germany

Berlin, Germany, 10115

Berlin, Germany, 13353
Netherlands

Groningen, Netherlands, 9713 GZ
United Kingdom

Cambridge, Cambridgeshire, United Kingdom, CB23 2TN

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00537836 History of Changes
Other Study ID Numbers:	91544, 2007-001791-36, 310781
Study First Received:	September 28, 2007
Last Updated:	February 16, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Hot flushes
Therapy of hot flushes
17ß-estradiol (E2)
Hormone replacement therapy

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 22, 2013