Trial Condition(s):

Endometriosis

Safety and efficacy of SH T00660AA in treatment of endometriosis

Bayer Identifier:

91234

ClinicalTrials.gov Identifier:

NCT00225186

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal

168

Trial Dates

July2004

March2008

Phase

Could I receive a placebo?

Products

Visanne (Dienogest, BAY86-5258)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Investigative Site Heidelberg, Germany, 69115	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Tuebingen, Germany, 72076	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Greifswald, Germany, 17487	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Weißig, Germany, 01474	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lübeck, Germany, 23538	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Dippoldiswalde, Germany, 01744	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Gevelsberg, Germany, 58285	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Krumbach, Germany, 86381	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kalbe, Germany, 39624	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Torino, Italy, 10127	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Brescia, Italy, 25123	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kiev, Ukraine, 04210	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Chernivtsi, Ukraine, 58017	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Münster, Germany, 48129	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Aachen, Germany, 52074	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Nuernberg, Germany, 90419	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Giessen, Germany, 35392	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Leipzig, Germany, 04103	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Mühlheim, Germany, 63165	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Marienberg, Germany, 09496	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site München, Germany, 81241	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Cagliari, Italy, 09124	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Roma, Italy, 00165	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Napoli, Italy, 80138	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kiev, Ukraine, 01030	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kiev, Ukraine, 04050	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Vinnitsa, Ukraine, 21000	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kiev, Ukraine, 04107	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

Trial Design

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)

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Treatment

Allocation:

Non-randomized

Blinding:

Open Label

Assignment:

Single Group Assignment

Trial Arms:

Primary Outcome

Safety assessment of the drug
Timeframe: 12-18 months

Secondary Outcome

Efficacy (reduction of pelvic pain)
Timeframe: 12-18 months

Endometriosis

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

45 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information