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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185237
First received: September 9, 2005
Last updated: October 10, 2013
Last verified: October 2013
  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:


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
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.

  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
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 ClinicalTrials.gov identifier: NCT00185237

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185237     History of Changes
Other Study ID Numbers: 91441, 309120
Study First Received: September 9, 2005
Last Updated: October 10, 2013
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:
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
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 October 01, 2014