Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651599

Enrollment

Registered

2008-04-03

Start date

2004-07-31

Completion date

2005-05-31

Last updated

2014-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasomotor Symptoms

Keywords

Vasomotor symptoms, Vasomotor System

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.

Interventions

DRUGAngeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

DRUGPlacebo

Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Postmenopausal Korean women suffering from hot flushes

Exclusion criteria

* Standard

Design outcomes

Primary

Measure	Time frame
Hot flush (frequency and severity)	Daily in pre-treatment and treatment period

Secondary

Measure	Time frame
Menopausal symptoms	Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Urogenital symptoms	Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Assessment of bleeding	daily in pre-treatment and treatment period

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026