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

Inclusion criteria

• ✓. 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.
• ✓. 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.