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OpenTrials
Completed

NCT Number: NCT00651599

Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

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.

Completed

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Key information

Conditions

Vasomotor Symptoms

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Hot flush (frequency and severity)

    Time frame: Daily in pre-treatment and treatment period

Secondary outcomes

  1. Menopausal symptoms

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

  2. Urogenital symptoms

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

  3. Assessment of bleeding

    Time frame: daily in pre-treatment and treatment period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Apr 3, 2008
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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