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

NCT07228975 | Completed

• 1 other identifier: EndOK 2023-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Endometriosis

Keywords

endometriosis; Pain management; NSAIDs reduction; Parsely extract; Flavonoids; Anti-inflammatory; Dietary; Apigenin; Luteolin; rosemary extract; EndoGen; EndOK Green

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 8 and week 16

Secondary Outcomes (8)

• Change from baseline in Pain Intensity using Endometriosis Health Profile (EHP)-30 Questionnaire

  Baseline,week 8, week 16

• Change from baseline in quality of life evaluated using the Endometriosis Health Profile (EHP)-30 core questionnaire

  Baseline,week 8, week 16

• Change from baseline in quality of life measured by the Endometriosis Health Profile (EHP)-30 modular questionnaire

  Baseline,Week 8 and Week 16

• Incidence of treatment-emergent effects (Safety and Tolerability)

  Baseline, week 4, week 8, week 12 and week 16

• Measurement of Adherence to treatment

  Baseline,Week 4, week 8, week 12, week 16

Study Arms (1)

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

Dietary Supplement: MetrioFen Gocce

Interventions

MetrioFen Gocce DIETARY_SUPPLEMENT

Solution-20 drops per day (equal to about 1 ml) on an empty stomach.

MetrioFen Gocce

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Fertile female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Endok s.r.l.: lead
• Hippocrates Research: collaborator

Study Sites (7)

Site#4 - Via Nicola Tridente, 35

Bari, BA, 70125, Italy

Location

Site#1 - Via Europa, 67

Alzano Lombardo, BG, 24022, Italy

Location

Site#3 - Via Enrico De Nicola, 171

Camaiore, LU, 55041, Italy

Location

Site#6 - Capo di piazza Gianni Bartoli, 1

Trieste, TS, 34100, Italy

Location

Site#5 - Via Sabbionera, 45

Latisana, UD, 33053, Italy

Location

Site#2 - Borgo Sant'Agnese, 93

Portogruaro, VE, 30026, Italy

Location

Site#7 - Via S.Maria del Pozzo, 106

Somma Vesuviana, 80049, Italy

Location

MeSH Terms

Conditions

Endometriosis; Agnosia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluigi Corsetti, CEO

  ENDOK S.R.L. - Via di Valle Alessandra, 53, Rome (RM) - Italy

  STUDY DIRECTOR

• Luciano Serra, Chief Scientific Officer

  ENDOK S.R.L. - Via di Valle Alessandra, 53, Rome (RM) - Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: September 9, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)