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Completed

NCT Number: NCT00185237

Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

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

  • Evidence of postmenopausal status

Exclusion criteria

  • Contraindication to estrogen therapy

Treatment and study plan

Menostar (estradiol transdermal delivery system)

Drug

Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

Placebo

Drug

Placebo patch

Primary outcomes

  1. Relative change in frequency of hot flushes

    Time frame: 12 weeks

Secondary outcomes

  1. Change in intensity of hot flushes

    Time frame: 12 weeks

  2. Changes in vaginal pH

    Time frame: 12 weeks

  3. Changes in vaginal maturation index

    Time frame: 12 weeks

  4. Occurrence of urogenital symptoms

    Time frame: 12 weeks

  5. Change in MENQOL (menopausal quality of life questionaire)

    Time frame: 12 weeks

  6. Bleeding profile

    Time frame: 12 weeks

  7. Safety

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Dec 23, 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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