Primary Sjögren’s syndrome
Conditions
Interventions
20 mg estetrol per day during 28 days
Sponsors
EMC
Investigator-initiated study
Eligibility
Inclusion criteria
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. 3. Postmenopausal women ≥ 18 and ≤ 70 years of age at the time of screening. 4. Body mass index ≥18 and ≤32 kg/m2. 5. Have complaints consistent with oral and ocular dryness. 6. The screening laboratory test results must meet the following criteria: SSA and/or SSB positive.
Exclusion criteria
Exclusion criteria: 1. Have a history of alcohol or substance abuse within the preceding 6 months. 2. Have a history of malignancy. 3. Have a history of trombo-embolic events or a positive lupus anticoagulant. 4. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. 5. Clinically significant abnormal results of routine hematology, serum biochemistry, urinanalysis, in the opinion of the Investigator at screening, and/or known ECG abnormalities. 6. Known clinically significant abnormal mammogram (presence of any non-cystic mass) within one year before study start. 7. Known clinically significant abnormalities of the uterus and/or ovaries detected earlier by examination and/or ultrasound. 8. A cervical smear with clinically relevant abnormal cytology within one year before study. 9. Previous use of estrogen/progestogen. 10. Use of hormone containing implant at any time. 11. Contraindications for using steroids. 12. Any enzyme affecting drugs from 30 days prior to Day 1 (see Appendix I) and the use of griseofulvin, phenytoin, barbiturates, carbamazepine, rimfampicin, nelfinavir, ritonavir, ketonazole, primidone, oxcarbazepine, topiramate, felbamate, herbal remedies containing hypericum perforatum (St. John’s wort). 13. Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access. 14. Use of any investigational drug within 3 months prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary endpoints include: - improvement in quantitative levels of SSA and/or SSB - decrease in pilocarpine use during treatment - improvement in results of SF36 | — |
Contacts
Public ContactS.A.M. Ennecker-Jans
Erasmus Medical Center
Outcome results
None listed