Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

April 22, 2010 updated by: Bayer

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis

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)

198

Phase

  • Phase 3

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients with endometriosis-associated pelvic pain

Exclusion Criteria:

  • Pregnant or lactating women
  • history or suspicion of hormone dependent tumor
  • therapy resistant endometriosis
  • need for primary surgical treatment
  • any other conditions which forbid the participation.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Visanne (BAY86-5258, SH T00660AA)
orally once daily
Placebo Comparator: Arm 2
Drug: Placebo
orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: Assessment of pain relief at end of treatment
Assessment of pain relief at end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event collection
Time Frame: Assessment at end of study
Assessment at end of study
Treatment satisfaction by patient
Time Frame: Assessment at end of study
Assessment at end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

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

March 1, 2004

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91233
  • 307041 (Other Identifier: IRAS Number)

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.

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