EndometriosisNCT07228975
Pilot Study on a Dietary Supplement With EndoGen™ as Adjunct Therapy in Women With Endometriosis
A study testing MetrioFen Gocce in people with Endometriosis, run by Endok s.r.l. at 7 sites in Italy.
Trial summary
Current treatments for endometriosis, such as NSAIDs and hormone therapies, are meant for long-term use but often cause side effects, including stomach, liver, heart, and kidney issues; allergies; and hormonal problems like weight gain, acne, and bone loss. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- MetrioFen Gocce
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 7 sitesItaly
- Study dates
- 9 Sep 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent, signed and dated personally by the patient.
- Female between the ages of 18 and 45 (including limits), with no race limitation.
- Documented endometriosis, confirmed by laparoscopy, ultrasound, or MRI, with or without biopsy, performed up to 36 months prior to the start of this investigation and independently of it.
- Stable health condition and stable drug treatments within the past 2 months.
- Endometriosis with a grade 2 (mild) to grade 4 (severe) AFSr score, whether or not treated with sex hormones, contraceptives, or any other specific treatment, stable for a minimum of 2 months. Note: In a first phase of the investigation, patients in class 2 and 3 will be recruited, while in a second phase, patients in class 4 will also be recruited.
- 10-point Visual Analogue Scale (VAS) score of pain due to endometriosis of at least 4 for at least 2 days in the 4 weeks prior to run-in.
Show all 20Show fewer
- Inclusion criteria for treatment initiation Patients will start treatment with EndOK Green if they meet all of the following criteria.
- Negative urine pregnancy test.
- Difference, for at least two days, of no more than 10 in the 10-point Visual Analogue Scale (VAS) (10%) between the 4 weeks prior to the screening visit and the end of the run-in phase, provided that at least one menstruation occurred in the period.
- No change in background therapy.
- Exclusion Criteria Patients will be excluded if they meet even one of the following criteria:
- Pregnancy, breastfeeding, or intending to become pregnant during the time this investigation will be conducted.
- Absence of cycles for at least 3 months.
- Previous hysterectomy or oophorectomy.
- Pelvic inflammatory disease regardless of its etiology (Chlamydia Trachomatis, Neisseria gonorrhoeae, fungi, etc.) or presence of ovarian cysts.
- Known hypersensitivity or allergy to the active substances and/or any component of the product under investigation.
- Patient who has taken, within 4 weeks prior to inclusion, or is currently taking, dietary supplements for the treatment of pelvic pain or other symptoms of endometriosis.
- Participation in any clinical study that has been ongoing or concluded for less than three months.
- Patient with one or more psychiatric disorders, such as alcoholism, substance abuse or addictive disorder, bipolar disorder, schizophrenia, or other personality disorders.
- Patient who, in the opinion of the gynecologist, will not be able to meet the prerequisites required for this investigation.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Site#1 - Via Europa, 67
Alzano Lombardo, BG, 24022
Site#4 - Via Nicola Tridente, 35
Bari, BA, 70125
Site#3 - Via Enrico De Nicola, 171
Camaiore, LU, 55041
Site#5 - Via Sabbionera, 45
Latisana, UD, 33053
Site#2 - Borgo Sant'Agnese, 93
Portogruaro, VE, 30026
Site#7 - Via S.Maria del Pozzo, 106
Somma Vesuviana, 80049
Site#6 - Capo di piazza Gianni Bartoli, 1
Trieste, TS, 34100
About this study
Official title: Pilot, Non-pharmacological Clinical Investigation to Evaluate the Efficacy and Tolerability of a Dietary Supplement Containing EndoGen™ as an Adjunct Treatment to Current Therapy, in Endometriosis Symptoms in Fertile Women With Confirmed Diagnosis
Current treatments for endometriosis, such as NSAIDs and hormone therapies, are meant for long-term use but often cause side effects, including stomach, liver, heart, and kidney issues; allergies; and hormonal problems like weight gain, acne, and bone loss. Therefore, one option being studied is a food supplement based on parsley extract (Petroselinum crispum), rosemary extract (Rosmarinus Officinalis L.), and selenium, combined with mountain celery and Vitamins B6, D, and E. The study's goal is to show improvement in pain and reduced use of NSAIDs in fertile women with endometriosis.
Read the detailed description
This is a small, early-stage study designed to test whether a four-month treatment with EndOK Green-a supplement made from EndoGen (TM), a mixture based on parsley extract (Petroselinum crispum), rosemary extract (Rosmarinus Officinalis L.), and selenium-can help reduce pain and lower the need for NSAIDs in women with moderate endometriosis (classified as stage 2 to 4 by the American Fertility Society). EndOK Green extract contains natural compounds like flavonoids (apigenin and luteolin), myristicin, and apiol, which may help ease symptoms through anti-inflammatory, antioxidant, and hormone-balancing effects, with fewer side effects than standard medications. This study includes a 4-week observational run-in period designed to exclude patients who show a clinically meaningful response without receiving any additional treatment.
Following this period, the investigational product will be administered for 16 consecutive weeks. Treatment responders will be defined as patients who meet either of the following criteria during the last 4 weeks of the treatment phase, specifically during the menstrual period:
A reduction of at least 20% from baseline on the VAS100 pain scale (e.g., if baseline pain is 8, a score of 6.4 is sufficient), and/or a 50% reduction from baseline in exposure (duration or dosage) of NSAIDs or other pain relievers.
- Conditions
- Endometriosis
- Being tested
- MetrioFen Gocce
- Keywords
- endometriosis, Pain management, NSAIDs reduction, Parsely extract, Flavonoids, Anti-inflammatory, Dietary, Apigenin, Luteolin, rosemary extract, EndoGen, EndOK Green
- Medical subject headings
- Endometriosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetrioFen GocceDietary supplement
Solution-20 drops per day (equal to about 1 ml) on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| MetrioFen Gocce | Experimental | EndOK Green contains EndoGen (TM)-an oral dose (10 drops per administration) twice daily of parsley extract, rosemary extract, other substances with Apigenin and Luteolin in hydro-alcoholic solution Receives: Dietary Supplement: MetrioFen Gocce |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants identified as a responder
Assessed using the 10-point Visual Analogue Scale (VAS) or use of NSAIDs or pain relievers. A "Treatment responder" will be defined as a reduction from baseline of at least 20% change in the 10-point Visual Analogue Scale (VAS) in the last 04 weeks during the menstrual phase or a 50% reduction from baseline in exposure (duration or dosage) to NAIDs or pain relievers.
Measured: Baseline, week 8 and week 16
Secondary outcomes (8)
Change from baseline in Pain Intensity using Endometriosis Health Profile (EHP)-30 Questionnaire
To assess the intensity of pain using the Endometriosis Health Profile (EHP)-30 Questionnaire. Scale of 0 to 100, where 0 indicates the best health status and 100 indicates the worst health status.
Measured: Baseline,week 8, week 16
Change from baseline in quality of life evaluated using the Endometriosis Health Profile (EHP)-30 core questionnaire
To assess Quality of Life using the Endometriosis Health Profile (EHP)-30 core (30 items) questionnaire. Scale of 0 to 100, where 0 indicates the best health status and 100 indicates the worst health status.
Measured: Baseline,week 8, week 16
Change from baseline in quality of life measured by the Endometriosis Health Profile (EHP)-30 modular questionnaire
To assess quality of life using the Endometriosis Health Profile (EHP)-30 modular questionnaire. Scale of 0 to 100, where 0 indicates the best health status and 100 indicates the worst health status.
Measured: Baseline,Week 8 and Week 16
Incidence of treatment-emergent effects (Safety and Tolerability)
Record of adverse events
Measured: Baseline, week 4, week 8, week 12 and week 16
Measurement of Adherence to treatment
Compliance by self-report tool questionnaire-yes or no question on if they adhered to the treatment, and if not, what was the percentage of doses not taken, and for what reason.
Measured: Baseline,Week 4, week 8, week 12, week 16
Changes in NSAID or other pain medication use
Evaluation of pain medications (dose and/or frequency), participant diary, and use of painkillers questionnaire
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Overall self-assessment of efficacy and tolerability using a 5-point scale
Overall efficacy and tolerability are rated on a 0 to 4 scale, with 0 being little to no effectiveness and/or tolerability and 4 being excellent effectiveness and/or tolerability.
Measured: Week 16
Overall physician-assessment of efficacy and tolerability using a 5-point scale
Overall efficacy and tolerability are rated on a 0 to 4 scale, with 0 being little to no effectiveness and/or tolerability and 4 being excellent effectiveness and/or tolerability.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start9 Sep 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endok s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Responsible party
- Sponsor
- Investigators
- Gianluigi Corsetti, CEO, Study director, ENDOK S.R.L. - Via di Valle Alessandra, 53, Rome (RM) - ItalyLuciano Serra, Chief Scientific Officer, Study director, ENDOK S.R.L. - Via di Valle Alessandra, 53, Rome (RM) - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228975
- Sponsor's protocol ID
- EndOK 2023-01
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Non-pharmacological Clinical Investigation to Evaluate the Efficacy and Tolerability of a Dietary Supplement Containing EndoGen™ as an Adjunct Treatment to Current Therapy, in Endometriosis Symptoms in Fertile Women With Confirmed Diagnosis
- ClinicalTrials.gov ID
- NCT07228975
- Acronym / sponsor ID
- EndOK 2023-01
- Conditions
- Endometriosis
- Keywords
- endometriosis, Pain management, NSAIDs reduction, Parsely extract, Flavonoids, Anti-inflammatory, Dietary, Apigenin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Endok s.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 14 Nov 2025 (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.
Current treatments for endometriosis, such as NSAIDs and hormone therapies, are meant for long-term use but often cause side effects, including stomach, liver, heart, and kidney issues; allergies; and hormonal problems like weight gain, acne, and bone loss. Therefore, one option being studied is a food supplement based on parsley extract (Petroselinum crispum), rosemary extract (Rosmarinus Officinalis L.), and selenium, combined with mountain celery and Vitamins B6, D, and E. The study's goal is to show improvement in pain and reduced use of NSAIDs in fertile women with endometriosis.
Detailed description
This is a small, early-stage study designed to test whether a four-month treatment with EndOK Green-a supplement made from EndoGen (TM), a mixture based on parsley extract (Petroselinum crispum), rosemary extract (Rosmarinus Officinalis L.), and selenium-can help reduce pain and lower the need for NSAIDs in women with moderate endometriosis (classified as stage 2 to 4 by the American Fertility Society). EndOK Green extract contains natural compounds like flavonoids (apigenin and luteolin), myristicin, and apiol, which may help ease symptoms through anti-inflammatory, antioxidant, and hormone-balancing effects, with fewer side effects than standard medications. This study includes a 4-week observational run-in period designed to exclude patients who show a clinically meaningful response without receiving any additional treatment.
Following this period, the investigational product will be administered for 16 consecutive weeks. Treatment responders will be defined as patients who meet either of the following criteria during the last 4 weeks of the treatment phase, specifically during the menstrual period:
A reduction of at least 20% from baseline on the VAS100 pain scale (e.g., if baseline pain is 8, a score of 6.4 is sufficient), and/or a 50% reduction from baseline in exposure (duration or dosage) of NSAIDs or other pain relievers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MetrioFen Gocce | Experimental | Dietary Supplement: MetrioFen GocceEndOK Green contains EndoGen (TM)-an oral dose (10 drops per administration) twice daily of parsley extract, rosemary extract, other substances with Apigenin and Luteolin in hydro-alcoholic solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Written informed consent, signed and dated personally by the patient.
- Female between the ages of 18 and 45 (including limits), with no race limitation.
- Documented endometriosis, confirmed by laparoscopy, ultrasound, or MRI, with or without biopsy, performed up to 36 months prior to the start of this investigation and independently of it.
- Stable health condition and stable drug treatments within the past 2 months.
- Endometriosis with a grade 2 (mild) to grade 4 (severe) AFSr score, whether or not treated with sex hormones, contraceptives, or any other specific treatment, stable for a minimum of 2 months. Note: In a first phase of the investigation, patients in class 2 and 3 will be recruited, while in a second phase, patients in class 4 will also be recruited.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MetrioFen GocceSolution-20 drops per day (equal to about 1 ml) on an empty stomach. | Dietary supplement | MetrioFen Gocce |
Primary outcome
Percentage of participants identified as a responder
Time frame: Baseline, week 8 and week 16
Assessed using the 10-point Visual Analogue Scale (VAS) or use of NSAIDs or pain relievers. A "Treatment responder" will be defined as a reduction from baseline of at least 20% change in the 10-point Visual Analogue Scale (VAS) in the last 04 weeks during the menstrual phase or a 50% reduction from baseline in exposure (duration or dosage) to NAIDs or pain relievers.
8 secondary outcomes
Change from baseline in Pain Intensity using Endometriosis Health Profile (EHP)-30 Questionnaire
Time frame: Baseline,week 8, week 16
Change from baseline in quality of life evaluated using the Endometriosis Health Profile (EHP)-30 core questionnaire
Time frame: Baseline,week 8, week 16
Change from baseline in quality of life measured by the Endometriosis Health Profile (EHP)-30 modular questionnaire
Time frame: Baseline,Week 8 and Week 16
Incidence of treatment-emergent effects (Safety and Tolerability)
Time frame: Baseline, week 4, week 8, week 12 and week 16
Measurement of Adherence to treatment
Time frame: Baseline,Week 4, week 8, week 12, week 16
Changes in NSAID or other pain medication use
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Overall self-assessment of efficacy and tolerability using a 5-point scale
Time frame: Week 16
Overall physician-assessment of efficacy and tolerability using a 5-point scale
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gianluigi Corsetti, CEO study director
ENDOK S.R.L. - Via di Valle Alessandra, 53, Rome (RM) - Italy
Luciano Serra, Chief Scientific Officer study director
ENDOK S.R.L. - Via di Valle Alessandra, 53, Rome (RM) - Italy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetrioFen Gocce in people with Endometriosis, run by Endok s.r.l. at 7 sites in Italy.
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 20 inclusion and 0 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants identified as a responder (time frame: Baseline, week 8 and week 16). 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 20 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.