Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00225199

Enrollment

198

Registered

2005-09-23

Start date

2004-03-31

Completion date

2006-09-30

Last updated

2010-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief summary

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

Detailed 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.

Interventions

DRUGVisanne (BAY86-5258, SH T00660AA)

orally once daily

DRUGPlacebo

orally once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Efficacy	Assessment of pain relief at end of treatment

Secondary

Measure	Time frame
Adverse event collection	Assessment at end of study
Treatment satisfaction by patient	Assessment at end of study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026