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OpenTrials
Completed

NCT Number: NCT00225186

Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Heidelberg, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or need for primary surgical treatment
  • Any other conditions which forbid the participation

Treatment and study plan

Visanne (SH T00660AA , BAY86-5258)

Drug

Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients

Primary outcomes

  1. Safety assessment of the drug

    Time frame: 12-18 months

Secondary outcomes

  1. Efficacy (reduction of pelvic pain)

    Time frame: 12-18 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 23, 2005
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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