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

Korábbi kezelés

• Previous hysterectomy or oophorectomy.
• 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.

Más betegség

• 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 with one or more psychiatric disorders, such as alcoholism, substance abuse or addictive disorder, bipolar disorder, schizophrenia, or other personality disorders.

Egyéb

• Pregnancy, breastfeeding, or intending to become pregnant during the time this investigation will be conducted.
• Absence of cycles for at least 3 months.
• Participation in any clinical study that has been ongoing or concluded for less than three months.
• Patient who, in the opinion of the gynecologist, will not be able to meet the prerequisites required for this investigation.

• 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.
• No change in background therapy.