NCT07228975

Pilot Study on a Dietary Supplement With EndoGen™ as Adjunct Therapy in Women With Endometriosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Endok s.r.l. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MetrioFen Gocce	Solution-20 drops per day (equal to about 1 ml) on an empty stomach.

Timeline

• Start date: 2024-09-09
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2025-11-14
• Last updated: 2025-11-20

Locations

7 sites across 1 country: Italy