Menorrhagia Study in Women With Treatment-resistant Menorrhagia

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00288691
• Collaborator: TAP Pharmaceutical Products Inc. (Industry)
• Enrollment: 26
• Arms: 4
• Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Drug: Asoprisnil (BAY86-5294); Drug: Asoprisnil (BAY86-5294); Drug: Asoprisnil (BAY86-5294); Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2001
• Actual Study Completion Date: Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Asoprisnil (BAY86-5294); 5mg/day
Experimental: Arm 2	Drug: Asoprisnil (BAY86-5294); 10mg/day
Experimental: Arm 3	Drug: Asoprisnil (BAY86-5294); 25mg/day
Placebo Comparator: Arm 4	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Individual relative change in uterine bleeding scores by PBAC [Pretreatment cycle treatment phase]

Secondary Outcome Measures

1. Endometrial thickness [End of treatment]

2. Adverse events collection [Whole treatment period]

3. Bleeding pattern [Treatment period]

4. Endometrial histology incl. immunohistochemical evaluations [End of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria:

• Organic causes of menorrhagia

• Current hormone treatment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer
• TAP Pharmaceutical Products Inc.

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00288691
• Other Study ID Numbers: 90955; 304667
• First Posted: Feb 8, 2006
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by , ,: Treatment-resistant menorrhagia
• Additional relevant MeSH terms: Menorrhagia

Study Results

No Results Posted as of Dec 30, 2014