Estetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept Study

Phase 2

Completed

Conditions: sicca syndrome and kerato-conjunctivitis and xerostomia
10003816

Registration Number: NL-OMON33531

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

Have the capacity to understand and sign an informed consent form
Fulfill American-European consensus criteria for primary Sjögren*s syndrome
Post menopausal women > 18 and < 75 years of age.
Have complaints consistent with oral and ocular dryness.

Exclusion Criteria

Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results.
Have a history of malignancy
Have a history of trombo-embolic events or a positive lupus anticoagulant
Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
Use of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Combined endopoint consisting of eyesymptoms, mouthsymptoms and laboratory<br /><br>values. Improvent of 20% or more on two of the three domains.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives include: improvement in quantitative levels of SSA and/ or<br /><br>SSB.<br /><br>Decrease in pilocarpine use during treatment. Furthermore improvent in results<br /><br>of the SF36</p><br>