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

Sponsor:	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: Estradiol/DRSP (Angeliq, BAY86-4891) Drug: Placebo	Phase III

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-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.

Resource links provided by NLM:

MedlinePlus related topics: Menopause

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

U.S. FDA Resources

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
Active Comparator: Arm 1	Drug: Estradiol/DRSP (Angeliq, BAY86-4891) Drospirenone (DRSP) 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.
Placebo Comparator: Arm 2	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, Hubei province

Wuhan, Hubei province, China, 430022
China, Jiangsu

Nanjing, Jiangsu, China, 210029
China, Shandong

Jinan, Shandong, China, 250012
China

Beijing, China, 100020

Beijing, China

Beijing, China, 100034

Beijing, China, 100083

Chongqing, China

Shanghai, China

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

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00356447 History of Changes
Other Study ID Numbers:	91442, 309341
Study First Received:	July 25, 2006
Last Updated:	September 23, 2011
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Drospirenone
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
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012