Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00225186

Enrollment

168

Registered

2005-09-23

Start date

2004-07-31

Completion date

2008-03-31

Last updated

2014-01-09

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 for 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 (SH T00660AA , BAY86-5258)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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

Design outcomes

Primary

Measure	Time frame
Safety assessment of the drug	12-18 months

Secondary

Measure	Time frame
Efficacy (reduction of pelvic pain)	12-18 months

Countries

Germany, Italy, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026