Endometriosis (Diagnosis)ENDOLIRALNCT07393958
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
A study testing Food supplement (T1675) in people with Endometriosis (Diagnosis), run by Arafarma Group, S.A. at 1 site in Spain.
Trial summary
This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with placebo, over several weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis (Diagnosis)
- What is being tested?
- Food supplement (T1675)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2026to 15 Sep 2027
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of reproductive age with diagnosed endometriosis stage I, II, or III, according to the American Society for Reproductive Medicine (ASRM) classification.
- Women with a diagnosis of endometriosis confirmed by laparoscopy or, in the absence of laparoscopy, by magnetic resonance imaging (MRI) and/or ultrasound.
- Presence of pelvic pain (VAS > 4) during the last three months.
- No indication for surgical intervention at the time of inclusion in the study.
- Patients who are able to provide informed consent.
Who cannot join
- Patients under 18 years of age.
- Use of analgesic or anti-inflammatory pharmacological treatment, except for ibuprofen at doses up to 600 mg/day or naproxen at doses up to 500 mg/day.
- Surgery within the year prior to inclusion, performed for therapeutic purposes related to the pathology under study.
- Initiation or discontinuation of hormone therapy within the three months prior to inclusion in the study.
- Patients with known allergy or hypersensitivity to Doliral®.
- Pregnant or breastfeeding patients.
- Patients on sick leave: > 1 year, or With no intention of returning to work, or Undergoing a disability or permanent incapacity assessment process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Tamara Rodíguez Licensed Physician, Specialist in Rheumatology, Dr, 93 227 54 00, tlrodriguez@clinic.cat
About this study
Official title: Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo.
This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with placebo, over several weeks.
Read the detailed description
Patients included into the study will be randomized into two treatment groups (30:30 patients). 30 patients will be treated with the food supplement and 30 patients will be treated with placebo. Both groups will be stratified by the presence or absence of hormonal therapy. Patients will be required to attend 6 study visits (selection visit, baseline or visit 0, and visits 1, 2, 3 and final or visit 4). Patients will complete a daily endometriosis symptom diary, which also includes a record of anti-inflammatory and paing medication use. Study treatment will be administred at Visit 0 or Baseline until Visit 4 or Final. At the study visits, patients will be requested to confirm the pain intensity through the VAS scale for different endometriosis pain types. They will be also requested to complete several questionnaires about quality of life.
- Conditions
- Endometriosis (Diagnosis)
- Being tested
- Food supplement (T1675), Placebo
- Keywords
- pain, QoL, food supplement
- Medical subject headings
- Endometriosis, Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplement (T1675)Dietary supplement
Doliral is the food supplement, which is the investigational product at this study.
PlaceboOther
Placebo is the control treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Food supplement-Doliral) | Experimental | Patient takes one buccal tablet per day. Receives: Dietary Supplement: Food supplement (T1675) |
| Control (Placebo) | Placebo comparator | Patient takes one buccal tablet per day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the improvement of the quality of life.
Patients complete EQ-5D-5L questionnaire at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). This questionnaire measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression and health status. These five dimensions have 5 response levels: No problems, slight problems, moderate problems, severe problems and extreme problems. This questionnaire also has a Visual Analogue Scale from 0 (worse health status) to 100 (best health status).
Measured: From baseline visit to the final visit at 12 weeks.
To measure the improvement of the quality of life.
Patients complete the Endometriosis Health Profile 30 Questionnaire at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). This questionnaire evaluates six domains: pain, control and powerlessness, emotional well-being, social support and self-image. These scales are converted into a 0-100 score, 0 is best health status and 100 is worse quality of life.
Measured: From baseline visit to the final visit at 12 weeks.
To measure the improvement of the quality of life.
Patients complete PGI-I (Patient Global Impression of Improvement) scale at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). PGI-I is a Likert scale from 1 (significantly better) to 7 (significantly worse).
Measured: From baseline visit to the final visit at 12 weeks.
To measure the improvement in pain intensity.
To describe the type and intensity of pain using a Visual Analogue Scale (VAS) at at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). It is measured the change of these results from baseline visit to the final visit. Also patients complete a symptoms diary between visits. For each symptom, the patient will record intensity (on a scale from 1 to 10).
Measured: From baseline visit to the final visit at 12 weeks.
Secondary outcomes (2)
Compare the reduction in the need for prescription and dosage of anti-inflammatory and analgesic pharmacological treatment.
Patients will complete the use of inflammatory and analgesic pharmacological treatment (name, dose and time) in a diary between visits.
Measured: From baseline visit to the final visit at 12 weeks.
To measure the incidence of clinically relevant episodes
To assess and destribe the type, intensity and relationship with investigational product of clinically relevant episodes at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4).
Measured: From Visit 1 (2 weeks) to Visit 4 or Final (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start26 Feb 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis (Diagnosis)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arafarma Group, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TAMARA RODRIGUEZ ARAYA, Dr, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393958
- Sponsor's protocol ID
- ARA-EXP/DOL-2025-01
- Acronym
- ENDOLIRAL
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo.
- ClinicalTrials.gov ID
- NCT07393958
- Acronym / sponsor ID
- ENDOLIRAL / ARA-EXP/DOL-2025-01
- Conditions
- Endometriosis (Diagnosis)
- Keywords
- pain, QoL, food supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Arafarma Group, S.A.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 6 Feb 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.
This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with placebo, over several weeks.
Detailed description
Patients included into the study will be randomized into two treatment groups (30:30 patients). 30 patients will be treated with the food supplement and 30 patients will be treated with placebo. Both groups will be stratified by the presence or absence of hormonal therapy. Patients will be required to attend 6 study visits (selection visit, baseline or visit 0, and visits 1, 2, 3 and final or visit 4). Patients will complete a daily endometriosis symptom diary, which also includes a record of anti-inflammatory and paing medication use. Study treatment will be administred at Visit 0 or Baseline until Visit 4 or Final. At the study visits, patients will be requested to confirm the pain intensity through the VAS scale for different endometriosis pain types. They will be also requested to complete several questionnaires about quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Food supplement-Doliral) | Experimental | Dietary Supplement: Food supplement (T1675)Patient takes one buccal tablet per day. |
| Control (Placebo) | Placebo comparator | Other: PlaceboPatient takes one buccal tablet per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women of reproductive age with diagnosed endometriosis stage I, II, or III, according to the American Society for Reproductive Medicine (ASRM) classification.
- Women with a diagnosis of endometriosis confirmed by laparoscopy or, in the absence of laparoscopy, by magnetic resonance imaging (MRI) and/or ultrasound.
- Presence of pelvic pain (VAS > 4) during the last three months.
- No indication for surgical intervention at the time of inclusion in the study.
- Patients who are able to provide informed consent.
Key exclusion criteria (7 listed)
- Patients under 18 years of age.
- Use of analgesic or anti-inflammatory pharmacological treatment, except for ibuprofen at doses up to 600 mg/day or naproxen at doses up to 500 mg/day.
- Surgery within the year prior to inclusion, performed for therapeutic purposes related to the pathology under study.
- Initiation or discontinuation of hormone therapy within the three months prior to inclusion in the study.
- Patients with known allergy or hypersensitivity to Doliral®.
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 |
|---|---|---|
| Food supplement (T1675)Doliral is the food supplement, which is the investigational product at this study. | Dietary supplement | Experimental (Food supplement-Doliral) |
| PlaceboPlacebo is the control treatment. | Other | Control (Placebo) |
Primary outcome
To measure the improvement of the quality of life.
Time frame: From baseline visit to the final visit at 12 weeks.
Patients complete EQ-5D-5L questionnaire at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). This questionnaire measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression and health status. These five dimensions have 5 response levels: No problems, slight problems, moderate problems, severe problems and extreme problems. This questionnaire also has a Visual Analogue Scale from 0 (worse health status) to 100 (best health status).
To measure the improvement of the quality of life.
Time frame: From baseline visit to the final visit at 12 weeks.
Patients complete the Endometriosis Health Profile 30 Questionnaire at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). This questionnaire evaluates six domains: pain, control and powerlessness, emotional well-being, social support and self-image. These scales are converted into a 0-100 score, 0 is best health status and 100 is worse quality of life.
To measure the improvement of the quality of life.
Time frame: From baseline visit to the final visit at 12 weeks.
Patients complete PGI-I (Patient Global Impression of Improvement) scale at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). PGI-I is a Likert scale from 1 (significantly better) to 7 (significantly worse).
To measure the improvement in pain intensity.
Time frame: From baseline visit to the final visit at 12 weeks.
To describe the type and intensity of pain using a Visual Analogue Scale (VAS) at at Day 1 (baseline visit), at 2 weeks (Visit 1), at 4 weeks (Visit 2), at 8 weeks (Visit 3) and at 12 weeks (Visit 4). It is measured the change of these results from baseline visit to the final visit. Also patients complete a symptoms diary between visits. For each symptom, the patient will record intensity (on a scale from 1 to 10).
2 secondary outcomes
Compare the reduction in the need for prescription and dosage of anti-inflammatory and analgesic pharmacological treatment.
Time frame: From baseline visit to the final visit at 12 weeks.
To measure the incidence of clinically relevant episodes
Time frame: From Visit 1 (2 weeks) to Visit 4 or Final (12 weeks).
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
TAMARA RODRIGUEZ ARAYA, Dr principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement (T1675) in people with Endometriosis (Diagnosis), run by Arafarma Group, S.A. at 1 site in Spain.
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 5 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: looking for participants now, as of the sponsor's last update on 30 Oct 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 Spain. 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.
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 Tamara Rodríguez Araya, Dr (+34 932 27 54 00, tlrodriguez@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the improvement of the quality of life. (time frame: From baseline visit to the final visit at 12 weeks.). The study lists 4 primary outcomes in all. 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 30 Oct 2026.