Treatment of Vasomotor Symptoms in Korean Post Menopausal Women - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00651599

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen 1,2-Dihydrospirorenone Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

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
Arm 2: Placebo Comparator	Drug: Placebo Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
Arm 1: Experimental	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:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91354, 308381
Study First Received:	April 1, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00651599 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:

Vasomotor symptoms
Vasomotor System

Additional relevant MeSH terms:

Estrogens
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Drospirenone
Hormones
Pharmacologic Actions
Estradiol

ClinicalTrials.gov processed this record on November 22, 2009