Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

Bayer168 enrolled

Overview

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

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

168

Conditions

Endometriosis

Interventions

Visanne (SH T00660AA , BAY86-5258)DRUG

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

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

Locations (28)

Unnamed facility

Heidelberg, Baden-Wurttemberg, Germany

Unnamed facility

Tübingen, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Safety assessment of the drug

Time frame: 12-18 months

Secondary Outcomes

Efficacy (reduction of pelvic pain)

Time frame: 12-18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.