Estetrol Therapy in Sjögren’s Syndrome: An Open Proof of Concept
Completed
- Conditions
- Primary Sjögren’s syndrome
- Registration Number
- NL-OMON22190
- Lead Sponsor
- EMCInvestigator-initiated study
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Have the capacity to understand and willing to sign an informed consent form.
2. Fulfill American-European consensus criteria for primary Sjögren’s syndrome.
Exclusion Criteria
1. Have a history of alcohol or substance abuse within the preceding 6 months.
2. Have a history of malignancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint consists of a composite endpoint concerning meaningful improvement across 2 or 3 Sjögren’s syndrome disease domains: oral, ocular and laboratory test
- Secondary Outcome Measures
Name Time Method Secondary endpoints include: <br /><br>- improvement in quantitative levels of SSA and/or SSB<br /><br>- decrease in pilocarpine use during treatment<br /><br>- improvement in results of SF36