check_circleStudy Completed

Endometriosis

Bayer Identifier:

91234

ClinicalTrials.gov Identifier:

NCT00225186

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and efficacy of SH T00660AA in treatment of endometriosis

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - Female patients with endometriosis-associated pelvic pain
  • - 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
July 2004 - March 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Heidelberg, 69115, Germany
Completed
Tuebingen, 72076, Germany
Completed
Greifswald, 17487, Germany
Completed
Weißig, 01474, Germany
Completed
Lübeck, 23538, Germany
Completed
Dippoldiswalde, 01744, Germany
Completed
Gevelsberg, 58285, Germany
Completed
Krumbach, 86381, Germany
Completed
Kalbe, 39624, Germany
Completed
Torino, 10127, Italy
Completed
Brescia, 25123, Italy
Completed
Kiev, 04210, Ukraine
Completed
Chernivtsi, 58017, Ukraine
Completed
Münster, 48129, Germany
Completed
Aachen, 52074, Germany
Completed
Nuernberg, 90419, Germany
Completed
Giessen, 35392, Germany
Completed
Leipzig, 04103, Germany
Completed
Mühlheim, 63165, Germany
Completed
Marienberg, 09496, Germany
Completed
München, 81241, Germany
Completed
Cagliari, 09124, Italy
Completed
Roma, 00165, Italy
Completed
Napoli, 80138, Italy
Completed
Kiev, 01030, Ukraine
Completed
Kiev, 04050, Ukraine
Completed
Vinnitsa, 21000, Ukraine
Completed
Kiev, 04107, Ukraine

Primary Outcome

  • Safety assessment of the drug
    date_rangeTime Frame:
    12-18 months
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Efficacy (reduction of pelvic pain)
    date_rangeTime Frame:
    12-18 months
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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