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Completed

NCT Number: NCT00356447

Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

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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

Wuhan, Hubei, China

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About this study

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion criteria

  • History of steroid hormone dependent malignant disease
  • Known or suspected malignant or premalignant disease
  • Current or history of severe heart, liver, renal, psychiatric disease
  • Hyperlipemia

Treatment and study plan

Estradiol/DRSP (Angeliq, BAY86-4891)

Drug

Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.

Placebo

Drug

Same administration.

Primary outcomes

  1. Frequency of hot flushes

    Time frame: From baseline to week 16

  2. Change in intensity of hot flushes

    Time frame: From baseline to week 16

Secondary outcomes

  1. Change in other climacteric symptoms

    Time frame: From baseline to week 16

  2. Vaginal Bleeding pattern

    Time frame: From baseline to week 16

  3. Global clinical impression

    Time frame: From baseline to week 16

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® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-day Treatment Cycles.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 26, 2006
Registry last updated
Oct 1, 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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