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

NCT07821320 | Not Yet Recruiting Phase 2

• 1 other identifier: Endometriose0926
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Endometriosis (Diagnosis); Endometriosis and Dysmenorrhea; Endometriosis Associated Pelvic Pain

Outcome Measures

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.

  from enrollment to the end of treatment at 150 days"

Secondary Outcomes (1)

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

  From enrollment to the end of treatment at 150 days

Study Arms (2)

Control-Group

PLACEBO COMPARATOR

Drug: Placebo

Drug-Group

ACTIVE COMPARATOR

Drug: Desloratadine

Interventions

Desloratadine DRUG

5mg daily

Drug-Group

Placebo DRUG

Placebo

Control-Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18-50
• By imaging (sonography or MRI) or surgery last 10 years confirmed endometriosis
• EHP-30 Score \> 40

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Endometriosis; Disease; Dysmenorrhea

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Marina Stjepic

CONTACT

+431404065190; marina.stjepic@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao. Univ.-Prof. Dr. med. univ. René Wenzl, MSc

Model Details: Model Description

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

AU (1)