Clinical Trials/NCT00288691

NCT00288691

Completed

Phase 2

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

Bayer0 sites26 target enrollmentNovember 2001

ConditionsMenorrhagia

InterventionsPlacebo Asoprisnil (BAY86-5294)

DrugsAsoprisnil (BAY86-5294)Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Menorrhagia
Sponsor: Bayer
Enrollment: 26
Primary Endpoint: Individual relative change in uterine bleeding scores by PBAC
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2001

End Date

January 2004

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria

•Organic causes of menorrhagia
•Current hormone treatment

Arms & Interventions

Arm 4

Intervention: Placebo

Arm 1

Intervention: Asoprisnil (BAY86-5294)

Arm 2

Intervention: Asoprisnil (BAY86-5294)

Arm 3

Intervention: Asoprisnil (BAY86-5294)

Outcomes

Primary Outcomes

Individual relative change in uterine bleeding scores by PBAC

Time Frame: Pretreatment cycle treatment phase

Secondary Outcomes

Endometrial thickness(End of treatment)
Adverse events collection(Whole treatment period)
Bleeding pattern(Treatment period)
Endometrial histology incl. immunohistochemical evaluations(End of treatment)

Similar Trials

Clinical Study Of Schizophrenia in Both Men and WomenSchizophrenia

NCT00071747GlaxoSmithKline176

SAMe Trial for Patients With Alcoholic CirrhosisAlcoholic Cirrhosis

NCT04250259Indiana University196

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisUlcerative Colitis

NCT02065557AbbVie101

12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking CessationSmoking Cessation

NCT00139750Pfizer600

A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety SymptomsMajor Depressive Disorder

NCT01582815Janssen Research & Development, LLC121