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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 9, 2005
Last updated: December 22, 2014
Last verified: December 2014
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Relative change in frequency of hot flushes [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change in intensity of hot flushes [ Time Frame: 12 weeks ]
  • Changes in vaginal pH [ Time Frame: 12 weeks ]
  • Changes in vaginal maturation index [ Time Frame: 12 weeks ]
  • Occurrence of urogenital symptoms [ Time Frame: 12 weeks ]
  • Change in MENQOL (menopausal quality of life questionaire) [ Time Frame: 12 weeks ]
  • Bleeding profile [ Time Frame: 12 weeks ]
  • Safety [ Time Frame: 12 weeks ]

Enrollment: 165
Study Start Date: July 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Evidence of postmenopausal status

Exclusion Criteria:

  • Contraindication to estrogen therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00185237

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00185237     History of Changes
Other Study ID Numbers: 91441
Study First Received: September 9, 2005
Last Updated: December 22, 2014

Keywords provided by Bayer:

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female processed this record on June 23, 2017