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OpenTrials
Completed

NCT Number: NCT00225199

Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

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

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
  • need for primary surgical treatment
  • any other conditions which forbid the participation.

Treatment and study plan

Visanne (BAY86-5258, SH T00660AA)

Drug

orally once daily

Placebo

Drug

orally once daily

Primary outcomes

  1. Efficacy

    Time frame: Assessment of pain relief at end of treatment

Secondary outcomes

  1. Adverse event collection

    Time frame: Assessment at end of study

  2. Treatment satisfaction by patient

    Time frame: Assessment at end of study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 23, 2005
Registry last updated
Apr 23, 2010

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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