ZK283197 for Treatment of Vasomotor Symptoms - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00537836

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

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
Arm 1: Experimental	Drug: BAY86-5310 (ZK283197) 3 mg ZK 283197, once daily p.o. over 8 weeks (n = 36)
Arm 2: Placebo Comparator	Drug: Placebo Placebo, once daily p.o. over 8 weeks (n = 36)
Arm 3: Experimental	Drug: BAY86-5310 (ZK283197) 2 mg ZK 283197, once daily p.o. over 8 weeks (n = 20)
Arm 4: Active Comparator	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, 13342

Berlin, Germany, 10115
Netherlands

Groningen, Netherlands, 9713 GZ
United Kingdom, Cambridgeshire

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:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91544, EudraCT-No.: 2007-001791-36, 310781
Study First Received:	September 28, 2007
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00537836 History of Changes
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

Study placed in the following topic categories:

Estrogens
Benzoates
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptive Agents, Female
Hot Flashes

Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate
Hormones
Estradiol
Estradiol 3-benzoate
Flushing
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate

Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate

ClinicalTrials.gov processed this record on September 11, 2009