Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

Bayer

Status and phase: Completed; Phase 3

Conditions: Endometriosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00225199

307041

91233

Details and patient eligibility

About

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in 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: 198 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
• need for primary surgical treatment
• any other conditions which forbid the participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Visanne (BAY86-5258, SH T00660AA)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo