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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 1, 2008
Last updated: December 30, 2014
Last verified: December 2014
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: Double Blind (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.


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

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.
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Please refer to this study by its identifier: NCT00651599

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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00651599     History of Changes
Other Study ID Numbers: 91354
Study First Received: April 1, 2008
Last Updated: December 30, 2014

Keywords provided by Bayer:
Vasomotor symptoms
Vasomotor System

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Drospirenone and ethinyl estradiol combination
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
Natriuretic Agents processed this record on April 26, 2017