Menorrhagia Study in Women With Treatment-resistant Menorrhagia

Phase 2

Completed

• Conditions: Menorrhagia
• Interventions: Drug: Asoprisnil (BAY86-5294); Drug: Placebo

• Registration Number: NCT00288691
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2001-11
• Study Completion: 2004-01
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria

• Organic causes of menorrhagia
• Current hormone treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Asoprisnil (BAY86-5294)	-
Arm 4	Placebo	-
Arm 1	Asoprisnil (BAY86-5294)	-
Arm 2	Asoprisnil (BAY86-5294)	-

Primary Outcome Measures

Name	Time	Method
Individual relative change in uterine bleeding scores by PBAC	Pretreatment cycle treatment phase

Secondary Outcome Measures

Name	Time	Method
Endometrial thickness	End of treatment
Adverse events collection	Whole treatment period
Bleeding pattern	Treatment period
Endometrial histology incl. immunohistochemical evaluations	End of treatment