Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Bayer90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Vasomotor Symptoms

Interventions

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)DRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (4)

Unnamed facility

Seoul, South Korea

Unnamed facility

Seoul, South Korea

Unnamed facility

Seoul, South Korea

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Hot flush (frequency and severity)

Time frame: Daily in pre-treatment and treatment period

Secondary Outcomes

Menopausal symptoms

Time frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment

Urogenital symptoms

Time frame: Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment

Assessment of bleeding

Time frame: daily in pre-treatment and treatment period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.