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OpenTrials
Completed

NCT Number: NCT00185328

Efficacy and Tolerability of Angeliq in Thai Women

To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

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Key information

Conditions

Postmenopause

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma 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

  • Postmenopausal women with hot flushes

Exclusion criteria

  • Women with a contraindication for Hormone Replacement Therapy (HRT)

Treatment and study plan

Estradiol/DRSP (Angeliq, BAY86-4891)

Drug

1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles

Primary outcomes

  1. The relative change in the frequency of hot flushes

    Time frame: At baseline, week 4, 8, 12

Secondary outcomes

  1. The change in intensity of hot flushes

    Time frame: At baseline, week 4, 8, 12

  2. The relative change in frequency of hot flushes

    Time frame: At baseline, week 4, 8

  3. The change in intensity of hot flushes

    Time frame: At baseline, week 4, 8

  4. The proportions of subjects with urogenital symptoms

    Time frame: At baseline, week 4, 8, 12

  5. Bleeding pattern

    Time frame: At baseline, week 4, 8, 12

  6. Adverse events collection

    Time frame: Collection of AE throughout the study period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles

Important dates

Study start
2005
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Dec 12, 2008

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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