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Trial record 96 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE
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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

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ClinicalTrials.gov Identifier: NCT00651599
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Vasomotor Symptoms Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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
Study Start Date : July 2004
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol

Arms and Interventions
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Arm Intervention/treatment
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.


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

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

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older 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
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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
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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
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00651599     History of Changes
Other Study ID Numbers: 91354
308381
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Vasomotor symptoms
Vasomotor System
Additional relevant MeSH terms:
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Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
Estradiol
Polyestradiol phosphate
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