Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

Bayer198 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

198

Conditions

Endometriosis

Interventions

Visanne (BAY86-5258, SH T00660AA)DRUG

orally once daily

PlaceboDRUG

orally once daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Efficacy

Time frame: Assessment of pain relief at end of treatment

Secondary Outcomes

Adverse event collection

Time frame: Assessment at end of study

Treatment satisfaction by patient

Time frame: Assessment at end of study

Data from ClinicalTrials.gov

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