Impact of the Antihistamine Desloratadine on the Quality of Life and Dysmenorrhea in Patients With Endometriosis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-50

By imaging (sonography or MRI) or surgery last 10 years confirmed endometriosis

EHP-30 Score > 40

Disqualifiers

Subject is unable or unwilling to participate

History of malignant diseases

Current immunosuppressant treatment

History of allergies and/or usage of antihistaminic treatments

Trial design

Design model

Parallel

Treatments tested in this trial

  • Desloratadine

    Drug

    5mg daily

  • Placebo

    Drug

    Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control-GroupPlacebo comparator 1 intervention
Group B: Drug-GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the Endometriosis-Health-Profile-30 (EHP-30) Score

The Score is used to measure the impact of Endometriosis on the quality of life. It is standardised on a scale from 0 to 100. 0 indicates the best health status whereas 100 indicates the worst health status.

Time frame
from enrollment to the end of treatment at 150 days"

Secondary outcomes

1

Change in Dysmenorrhea using the visual analogue scale (0-10)

Time frame
From enrollment to the end of treatment at 150 days

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: