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

Purpose

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

Safety and tolerability of Angeliq®.

Condition	Intervention	Phase
Vasomotor Symptoms	Drug: Angeliq® (2 mg drospirenone and 1 mg estradiol) Drug: Placebo	Phase III

MedlinePlus related topics:

Menopause

ChemIDplus related topics:

Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate 1,2-Dihydrospirorenone

U.S. FDA Resources

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

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 1: Experimental n/a	Drug: Angeliq® (2 mg drospirenone and 1 mg estradiol) Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
Arm 2: Placebo Comparator n/a	Drug: Placebo 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, 135-710

	Seoul, Korea, Republic of

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	( Bayer Schering Pharma AG, Therapeutic Area Head )
Study ID Numbers:	91354, 308381
First Received:	April 1, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00651599
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:

Vasomotor symptoms

Vasomotor System

Study placed in the following topic categories:

Estradiol 3-benzoate

Estradiol valerate

Drospirenone

Estradiol 17 beta-cypionate

Polyestradiol phosphate

Estradiol

Menopause

Additional relevant MeSH terms:

Estrogens

Aldosterone Antagonists

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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