check_circleStudy Completed

Endometriosis

Bayer Identifier:

91233

ClinicalTrials.gov Identifier:

NCT00225199

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and safety of SH T00660AA in treatment of endometriosis

Trial purpose

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in 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
    - need for primary surgical treatment
    - any other conditions which forbid the participation

Trial summary

Enrollment Goal
198
Trial Dates
March 2004 - September 2006
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Primary Outcome

  • Efficacy
    date_rangeTime Frame:
    Assessment of pain relief at end of treatment
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    Assessment at end of study
    enhanced_encryption
    Safety Issue:
    None
  • Treatment satisfaction by patient
    date_rangeTime Frame:
    Assessment at end of study
    enhanced_encryption
    Safety Issue:
    None

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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