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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00651599
First received: April 1, 2008
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.


Condition Intervention Phase
Vasomotor Symptoms
 Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Hot flush (frequency and severity) [ Time Frame: Daily in pre-treatment and treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Menopausal symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Urogenital symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Assessment of bleeding [ Time Frame: daily in pre-treatment and treatment period ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: July 2004
Study Completion Date: May 2005
Arms Assigned Interventions
Placebo Comparator: Arm 2 Drug: Placebo
Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
Experimental: Arm 1 Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal Korean women suffering from hot flushes

Exclusion Criteria:

  • Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651599

Locations
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of
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: NCT00651599     History of Changes
Other Study ID Numbers: 91354, 308381
Study First Received: April 1, 2008
Last Updated: July 14, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Vasomotor symptoms
Vasomotor System

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 May 16, 2013