Menorrhagia Study in Women With Treatment-resistant Menorrhagia
December 29, 2014 updated by: Bayer
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
The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with treatment-resistant menorrhagia scheduled for hysterectomy.
Exclusion Criteria:
- Organic causes of menorrhagia
- Current hormone treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
|
5mg/day
10mg/day
25mg/day
|
|
Experimental: Arm 2
|
5mg/day
10mg/day
25mg/day
|
|
Experimental: Arm 3
|
5mg/day
10mg/day
25mg/day
|
|
Placebo Comparator: Arm 4
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Individual relative change in uterine bleeding scores by PBAC
Time Frame: Pretreatment cycle treatment phase
|
Pretreatment cycle treatment phase
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Endometrial thickness
Time Frame: End of treatment
|
End of treatment
|
|
Adverse events collection
Time Frame: Whole treatment period
|
Whole treatment period
|
|
Bleeding pattern
Time Frame: Treatment period
|
Treatment period
|
|
Endometrial histology incl. immunohistochemical evaluations
Time Frame: End of treatment
|
End of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion
December 7, 2022
Study Completion (Actual)
January 1, 2004
Study Registration Dates
First Submitted
February 7, 2006
First Submitted That Met QC Criteria
February 7, 2006
First Posted (Estimate)
February 8, 2006
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 29, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90955
- 304667
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.