Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms. - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00356447

Purpose

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

Condition	Intervention	Phase
Vasomotor Symptoms	Drug: Angeliq Drug: Placebo	Phase III

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate 1,2-Dihydrospirorenone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-Day Treatment Cycles.

Further study details as provided by Bayer:

Primary Outcome Measures:

Frequency of hot flushes [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]
Change in intensity of hot flushes [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in other climacteric symptoms [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]
Vaginal Bleeding pattern [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: Yes ]
Global clinical impression [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]

Enrollment:	249
Study Start Date:	May 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Angeliq Drospirenone 2mg and estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles..Oral administration
Arm 2: Placebo Comparator	Drug: Placebo Same administration.

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

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

Criteria

Inclusion Criteria:

Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion Criteria:

History of steroid hormone dependent malignant disease
Known or suspected malignant or premalignant disease
Current or history of severe heart, liver, renal, psychiatric disease
Hyperlipemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356447

Locations

China

Beijing, China

Beijing, China, 100034

Beijing, China, 100083

beijing, China, 100020

Shanghai, China

Chongqing, China
China, Hubei province

Wuhan, Hubei province, China, 430022
China, Jiangsu

Nanjing, Jiangsu, China, 210029
China, Shandong

Jinan, Shandong, China, 250012

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:	91442, 309341
Study First Received:	July 25, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00356447
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Estradiol 3-benzoate
Estradiol valerate
Drospirenone

Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009