Trial Condition(s):
Endometriosis
Efficacy and safety of SH T00660AA in treatment of endometriosis
Bayer Identifier:
91233
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in 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 - need for primary surgical treatment - any other conditions which forbid the participation
Trial Summary
Enrollment Goal
198
Trial Dates
Phase
3
Could I receive a placebo?
Yes
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
|---|
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
Primary Outcome
- EfficacyTimeframe: Assessment of pain relief at end of treatment
Secondary Outcome
- Adverse event collectionTimeframe: Assessment at end of study
- Treatment satisfaction by patientTimeframe: Assessment at end of study
Additional Information
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