An interventional study of MetrioFen Gocce in Endometriosis, sponsored by Endok s.r.l.. Completed at 7 sites in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Endok s.r.l. · Not applicable, Interventional, and Treatment
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.
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 36 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →This is the only study on the registry with Endok s.r.l. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for the Initial Run-In Phase
Inclusion criteria for treatment initiation Patients will start treatment with EndOK Green if they meet all of the following criteria.
Exclusion Criteria Patients will be excluded if they meet even one of the following criteria:
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
Dietary Supplement: MetrioFen Gocce
Solution-20 drops per day (equal to about 1 ml) on an empty stomach.
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.
Time frame: Baseline, week 8 and week 16
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline,Week 8 and Week 16
Incidence of treatment-emergent effects (Safety and Tolerability)
Record of adverse events
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Week 16
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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