Menorrhagia Study in Women With Treatment-resistant Menor... | NCT00288691

Studies
Menorrhagia Study in Women With Treatment-resistant Menorrhagia

NCT00288691

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

26Actual

Phase

Phase 2

Conditions

Menorrhagia

Interventions

Asoprisnil (BAY86-5294)
Asoprisnil (BAY86-5294)
Asoprisnil (BAY86-5294)
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
304667

Official 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

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Not provided

Completion Date

Jan 2004Actual

First Submitted Date

Feb 7, 2006

First Submission Date that Met QC Criteria

Feb 7, 2006

First Posted Date

Feb 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Name	Class
TAP Pharmaceutical Products Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Experimental	Drug: Asoprisnil (BAY86-5294)
Arm 2	Experimental	Drug: Asoprisnil (BAY86-5294)
Arm 3	Experimental	Drug: Asoprisnil (BAY86-5294)
Arm 4	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Asoprisnil (BAY86-5294)	Drug	5mg/day	Arm 1
Asoprisnil (BAY86-5294)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Individual relative change in uterine bleeding scores by PBAC		Pretreatment cycle treatment phase

Secondary Outcomes

Measure	Description	Time Frame
Endometrial thickness		End of treatment
Adverse events collection		Whole treatment period
Bleeding pattern

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria:

Organic causes of menorrhagia
Current hormone treatment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D008595	Menorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C488516	asoprisnil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided