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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651599
First Posted: April 3, 2008
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Hot flush (frequency and severity) [ Time Frame: Daily in pre-treatment and treatment period ]

Secondary Outcome Measures:
  • Menopausal symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ]
  • Urogenital symptoms [ Time Frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment ]
  • Assessment of bleeding [ Time Frame: daily in pre-treatment and treatment period ]

Enrollment: 90
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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651599


Locations
Korea, Republic of
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00651599     History of Changes
Other Study ID Numbers: 91354
308381
First Submitted: April 1, 2008
First Posted: April 3, 2008
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Vasomotor symptoms
Vasomotor System

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Drospirenone and ethinyl estradiol combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents