The primary objective of this study will be overall response to treatment with Estetrol in patients with primary Sjogren*s syndrome.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Combined endopoint consisting of eyesymptoms, mouthsymptoms and laboratory
values. Improvent of 20% or more on two of the three domains.
Secondary outcome
Secondary objectives include: improvement in quantitative levels of SSA and/ or
SSB.
Decrease in pilocarpine use during treatment. Furthermore improvent in results
of the SF36
Background summary
Sjögren's syndrome is a chronic inflammatory disorder with a prevalence of 0,6
% in adults. It's characterized by lymphocytic infiltration of exocrine glands,
especially lacrimal and salivary glands. It is characterized by symptoms of dry
eyes (keratoconjunctivitis sicca) and dry mouth (xerostomia). Systemic
manifestations are subdivided into nonvisceral (skin, arhtralgia, myalgia) and
visceral (lung, heart, kidney and peripheral nervous system). Usually it*s not
lifethreatening and life expectancy is normal. However, the fatigue, eye
irritation and oral problems can have a negative impact on quality of life.
There is no known cure for this autoimmune disorder. The pathogenesis of
Sjogren's syndrome is unclear. Sjogren*s syndrome predominantly affects females
and its severity increases after menopause. Estrogenic action has been
suggested responsible for the strong female preponderance. This has been
confirmed in animalstudies. Estetrol is a physiological estrogen-like compound,
synthesized by the human fetal liver only and therefore present solely during
human pregnancy. Estetrol appears to exhibit a remarkably good oral absorption
and high bioavailability with a long elimination half-life of 28 hours. No
safety problems have been encountered during the pharmacological studies with
estetrol. In addition estetrol did not show interaction in a panel of 130 known
drug targets (receptors and enzymes), which confirms the high selectivity of
estetrol for the estrogen receptor and predicts a favorable safety profile.
Study objective
The primary objective of this study will be overall response to treatment with
Estetrol in patients with primary Sjogren*s syndrome.
Study design
This is a 3 monhts, single center study. Proof op principle. The patients will
be treated with estetrol during four weeks after a placebo run-in of four
weeks.
Intervention
Treatment with estetrol
Study burden and risks
Patients will undergo venipunctures four times. A Schirmer test will be
performed four times. Salivary flow will be measured four times during fifteen
minutes. Due to estetrol patients have a slightly increased risk on
trombo-embolic events.
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003537-16-NL |
| CCMO | NL18783.078.07 |