Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

Bayer

Status and phase: Completed; Phase 3

Conditions: Endometriosis

Treatments: Drug: Visanne (SH T00660AA , BAY86-5258)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00225186

91234

307059 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 168 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Visanne (SH T00660AA , BAY86-5258)