check_circleStudy Completed

Menorrhagia

Bayer Identifier:

90955

ClinicalTrials.gov Identifier:

NCT00288691

EudraCT Number:

Not Available

EU CT Number:

Not Available
Menorrhagia study in women with treatment-resistant menorrhagia

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

30 - 55 Years
  • - Patients with treatment-resistant menorrhagia scheduled for hysterectomy.
  • - Organic causes of menorrhagia
    - Current hormone treatment

Trial summary

Enrollment Goal
26
Trial Dates
November 2001 - January 2004
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Asoprisnil (BAY86-5294)
Accepts Healthy Volunteer
No

Primary Outcome

  • Individual relative change in uterine bleeding scores by PBAC
    date_rangeTime Frame:
    Pretreatment cycle treatment phase
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Endometrial thickness
    date_rangeTime Frame:
    End of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Adverse events collection
    date_rangeTime Frame:
    Whole treatment period
    enhanced_encryption
    Safety Issue:
    None
  • Bleeding pattern
    date_rangeTime Frame:
    Treatment period
    enhanced_encryption
    Safety Issue:
    None
  • Endometrial histology incl. immunohistochemical evaluations
    date_rangeTime Frame:
    End of treatment
    enhanced_encryption
    Safety Issue:
    None

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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