Trial Condition(s):
Endometriosis
Safety and efficacy of SH T00660AA in treatment of endometriosis
Bayer Identifier:
91234
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| 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: clin[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:
1
Primary Outcome
- Safety assessment of the drugTimeframe: 12-18 months
Secondary Outcome
- Efficacy (reduction of pelvic pain)Timeframe: 12-18 months
Additional Information
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