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NCT Number: NCT07821320

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

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.

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Key information

Conditions

Endometriosis Disease Dysmenorrhea Endometriosis (Diagnosis) Endometriosis Associated Pelvic Pain Endometriosis and Dysmenorrhea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

desloratadine

Drug

5mg daily

Placebo

Drug

Placebo

Primary outcomes

  1. Change in the EHP-30 Score

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Stjepic

CONTACT

[email protected]

+431404065190

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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