Trial Condition(s):
Menorrhagia
Menorrhagia study in women with treatment-resistant menorrhagia
Bayer Identifier:
90955
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- Patients with treatment-resistant menorrhagia scheduled for hysterectomy.
Exclusion Criteria
- Organic causes of menorrhagia - Current hormone treatment
Trial Summary
Enrollment Goal
26
Trial Dates
Phase
2
Could I receive a placebo?
Yes
Products
Asoprisnil (BAY86-5294)
Accepts Healthy Volunteers
No
Where to Participate
Locations
Status
| Locations | Status |
|---|
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
Primary Outcome
- Individual relative change in uterine bleeding scores by PBACTimeframe: Pretreatment cycle treatment phase
Secondary Outcome
- Endometrial thicknessTimeframe: End of treatment
- Adverse events collectionTimeframe: Whole treatment period
- Bleeding patternTimeframe: Treatment period
- Endometrial histology incl. immunohistochemical evaluationsTimeframe: End of treatment
Additional Information
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