Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185237

Purpose

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Condition	Intervention	Phase
Hot Flashes	Drug: Menostar (estradiol transdermal delivery system) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo Controlled Study on the Effect of Ultra-Low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-Being in Postmenopausal Asian Women Over 12 Weeks.

Resource links provided by NLM:

MedlinePlus related topics: Menopause

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:

Relative change in frequency of hot flushes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in intensity of hot flushes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in vaginal pH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in vaginal maturation index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Occurrence of urogenital symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in MENQOL (menopausal quality of life questionaire) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Bleeding profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	283
Study Start Date:	July 2005
Study Completion Date:	November 2006

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Menostar (estradiol transdermal delivery system) Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
Arm 2: Placebo Comparator	Drug: Placebo Placebo patch

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:

Evidence of postmenopausal status

Exclusion Criteria:

Contraindication to estrogen therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185237

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

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91441, 309120
Study First Received:	September 9, 2005
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00185237 History of Changes
Health Authority:	Singapore: Health Sciences Authority; Hong Kong: Department of Health; Malaysia: Ministry of Health; Thailand: Food and Drug Administration; Philippines: Bureau of Food and Drugs

Keywords provided by Bayer:

Menopause

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hot Flashes
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents

Estradiol 17 beta-cypionate
Hormones
Estradiol
Pharmacologic Actions
Signs and Symptoms
Therapeutic Uses
Estradiol 3-benzoate
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 09, 2009