Endometriosis, Endometriosis and Dysmenorrhea, Endometriosis Associated Pelvic Pain, Endometriosis (Diagnosis)
Conditions
Brief summary
Endometriosis is a chronic inflammatory disease affecting approximately 10% of women in their reproductive years. It is characterized by the presence of endometrial-like tissue outside the uterine cavity. Current treatment options include hormonal therapies or surgical excision of the endometriotic lesions. Although these interventions often lead to a significant symptom relief, some patients still experience persistent pain or treatment-related adverse effects. Consequently, the management of dysmenorrhea and improvement of quality of life in patients with endometriosis remain a clinical challenge. Desloratadine is widely used for the treatment of allergic rhinitis or chronic urticaria. Recent studies suggest that desloratadine may also possess analgesic and anti-inflammatory properties. So far, however, no clinical studies have investigated its potential therapeutic effects in patients with endometriosis. Therefore, the present study aims to provide the first clinical assessment of the efficacy, safety and tolerability of desloratadine in patients with endometriosis.
Interventions
DRUGDesloratadine
5mg daily
DRUGPlacebo
Placebo
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking Description
Intervention model description
Model Description
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-50 * By imaging (sonography or MRI) or surgery last 10 years confirmed endometriosis * EHP-30 Score \> 40
Exclusion criteria
* Subject is unable or unwilling to participate * History of malignant diseases * Current immunosuppressant treatment * History of allergies and/or usage of antihistaminic treatments * Postmenopausal women * Current hormonal treatment * Surgical treatment \<1year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the EHP-30 Score | from enrollment to the end of treatment at 150 days" |
Secondary
| Measure | Time frame |
|---|---|
| Change in Dysmenorrhea using the visual analogue scale (0-10) | From enrollment to the end of treatment at 150 days |
Countries
Austria
Contacts
CONTACTMarina Stjepic
Outcome results
None listed