EndometriosisPhase 2NCT07821320
Impact of the Antihistamine Desloratadine on the Quality of Life and Dysmenorrhea in Patients With Endometriosis
A Phase 2 study testing Desloratadine in people with Endometriosis and Endometriosis (Diagnosis), run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis (Diagnosis), Endometriosis and Dysmenorrhea
- What is being tested?
- Desloratadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2027to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-50
- By imaging (sonography or MRI) or surgery last 10 years confirmed endometriosis
- EHP-30 Score > 40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Vienna
Vienna, 1090
Marina Stjepic, +4314040065190, marina.stjepic@meduniwien.ac.at
About this study
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
- Being tested
- Desloratadine, Placebo
- Medical subject headings
- Endometriosis, Disease, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
5mg daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control-Group | Placebo comparator | Not described Receives: Drug: Placebo |
| Drug-Group | Active comparator | Not described Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to the end of treatment at 150 days"
Secondary outcomes (1)
Change in Dysmenorrhea using the visual analogue scale (0-10)
Measured: From enrollment to the end of treatment at 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, René Wenzl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821320
- Sponsor's protocol ID
- Endometriose0926
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Antihistamine Desloratadine on the Quality of Life and Dysmenorrhea in Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT07821320
- Acronym / sponsor ID
- Endometriose0926
- Conditions
- Endometriosis, Endometriosis (Diagnosis), Endometriosis and Dysmenorrhea, Endometriosis Associated Pelvic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Control-Group | Placebo comparator | Drug: Placebo |
| Drug-Group | Active comparator | Drug: Desloratadine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients aged 18-50
- By imaging (sonography or MRI) or surgery last 10 years confirmed endometriosis
- EHP-30 Score > 40
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desloratadine5mg daily | Drug | Drug-Group |
| PlaceboPlacebo | Drug | Control-Group |
Primary outcome
Change in the Endometriosis-Health-Profile-30 (EHP-30) Score
Time frame: from enrollment to the end of treatment at 150 days"
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.
1 secondary outcome
Change in Dysmenorrhea using the visual analogue scale (0-10)
Time frame: From enrollment to the end of treatment at 150 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desloratadine in people with Endometriosis and Endometriosis (Diagnosis), run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Stjepic (+431404065190, marina.stjepic@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Endometriosis-Health-Profile-30 (EHP-30) Score (time frame: from enrollment to the end of treatment at 150 days"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.