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Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vasomotor Symptoms

Intervention: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hot flush (frequency and severity)

Secondary outcome:

Menopausal symptoms

Urogenital symptoms

Assessment of bleeding

Eligibility

Minimum age: 45 Years. Maximum age: 65 Years. Gender(s): Female.

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.

Locations and Contacts

Seoul 110-744, Korea, Republic of

Seoul 135-710, Korea, Republic of

Seoul 138-736, Korea, Republic of

Seoul, Korea, Republic of

Additional Information

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Starting date: July 2004
Last updated: December 30, 2014

Page last updated: August 23, 2015

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