Flexofytol® for the Treatment of Endometriosis- Associated Pain

Launched by MEDICAL UNIVERSITY OF VIENNA · Oct 31, 2019

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Premenopausal women between the ages of 18 and 51 years
• • Ability to comprehend the full nature and purpose of the study
• • Signed informed consent
• • Diagnosed endometriosis (peritoneal, ovarian or deep-infiltrating endometriosis (DIE))
• • By laparoscopy or laparotomy with histological verification diagnosed up to 10 years before screening
• • By ultrasound or MRI (ovarian or deep-infiltrating endometriosis, as peritoneal lesions can only be evaluated surgically)
• • Moderate to severe pelvic pain (i.e. dysmenorrhea or NMPP of at least 4 on the 1-10 NRS) at least during the past 3 months
• • Refusal of hormonal treatments
• • The patient must agree to switch from her usual analgesic rescue medication to only the one permitted by the study during screening, treatment and follow-up period
• Exclusion Criteria:
• • The patient is pregnant or breast feeding or is planning a pregnancy within the treatment period
• • Known addiction (alcohol, drugs, pills, etc...)
• • Liver or kidney problems
• • Known problems of the bile system
• • Infection (HIV, Hepatitis, TBC, etc..) or systemic autoimmune diseases
• • Known or suspected malignant disease
• • Intake of blood-thinning medication (such as heparin or aspirin for example)
• • Intake of hormonal contraceptives (oral during the last 4 weeks, injectable: during the last 3 months)
• • Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial ablation resulting in amenorrhea