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Completed

NCT Number: NCT00288691

Menorrhagia Study in Women With Treatment-resistant Menorrhagia

The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

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

  • Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion criteria

  • Organic causes of menorrhagia
  • Current hormone treatment

Treatment and study plan

Asoprisnil (BAY86-5294)

Drug

5mg/day

Placebo

Drug

Placebo

Primary outcomes

  1. Individual relative change in uterine bleeding scores by PBAC

    Time frame: Pretreatment cycle treatment phase

Secondary outcomes

  1. Endometrial thickness

    Time frame: End of treatment

  2. Adverse events collection

    Time frame: Whole treatment period

  3. Bleeding pattern

    Time frame: Treatment period

  4. Endometrial histology incl. immunohistochemical evaluations

    Time frame: End of treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • TAP Pharmaceutical Products Inc.

Registry information

Official study title

A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days

Important dates

Study start
2001
Study completion
2004
First posted
Feb 8, 2006
Registry last updated
Dec 30, 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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