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: ZK 283197 Drug: Placebo Drug: 17ß-estradiol	Phase II

Drug Information available for:

Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate

U.S. FDA Resources

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.

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 ]

Estimated Enrollment:	112
Study Start Date:	October 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: ZK 283197 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: ZK 283197 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

Contacts


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

Contact: For trial location information (Phone Menu Options "3" or "4")	(ex US:+1)1-888-84-22937

Locations


Germany
		Recruiting
	Berlin, Germany, 13342
		Recruiting
	Berlin, Germany, 10115

Netherlands
		Recruiting
	Groningen, Netherlands, 9713 GZ

United Kingdom, Cambridgeshire
		Recruiting
	Cambridge, Cambridgeshire, United Kingdom, CB23 2TN

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91544, EudraCT-No.: 2007-001791-36, 310781
First Received:	September 28, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00537836
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Institutional Review Board

Keywords provided by Bayer:

Hot flushes

Therapy of hot flushes

17ß-estradiol (E2)

Hormone replacement therapy

Study placed in the following topic categories:

Benzoates

Estradiol 3-benzoate

Estradiol valerate

Hot Flashes

Flushing

Estradiol 17 beta-cypionate

Polyestradiol phosphate

Estradiol

Additional relevant MeSH terms:

Estrogens

Contraceptive Agents

Therapeutic Uses

Physiological Effects of Drugs

Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

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