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NCT00288691 Clinical Trial

Menorrhagia Study in Women With Treatment-resistant Menorrhagia

Menorrhagia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00288691
Other study ID # 90955
Secondary ID 304667
Status Completed
Phase Phase 2
First received February 7, 2006
Last updated December 29, 2014
Start date November 2001
Est. completion date January 2004

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 55 Years
Eligibility Inclusion Criteria:

- Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria:

- Organic causes of menorrhagia

- Current hormone treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Asoprisnil (BAY86-5294)
5mg/day
• Asoprisnil (BAY86-5294)
10mg/day
• Asoprisnil (BAY86-5294)
25mg/day
• Placebo
Placebo

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bayer TAP Pharmaceutical Products Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Individual relative change in uterine bleeding scores by PBAC Pretreatment cycle treatment phase
Secondary Endometrial thickness End of treatment
Secondary Adverse events collection Whole treatment period
Secondary Bleeding pattern Treatment period
Secondary Endometrial histology incl. immunohistochemical evaluations End of treatment
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