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Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225199
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : April 23, 2010
Sponsor:
Information provided by:
Bayer

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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Visanne (BAY86-5258, SH T00660AA) Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2004
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Arm 1 Drug: Visanne (BAY86-5258, SH T00660AA)
orally once daily

Placebo Comparator: Arm 2 Drug: Placebo
orally once daily




Primary Outcome Measures :
  1. Efficacy [ Time Frame: Assessment of pain relief at end of treatment ]

Secondary Outcome Measures :
  1. Adverse event collection [ Time Frame: Assessment at end of study ]
  2. Treatment satisfaction by patient [ Time Frame: Assessment at end of study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225199


Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00225199    
Other Study ID Numbers: 91233
307041
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female