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Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185237
First received: September 9, 2005
Last updated: April 13, 2010
Last verified: April 2010
History of Changes
  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 3

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

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185237     History of Changes
Other Study ID Numbers: 91441, 309120
Study First Received: September 9, 2005
Last Updated: April 13, 2010
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:
Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
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

ClinicalTrials.gov processed this record on June 18, 2013