Status:
TERMINATED
Evaluation of a Nutraceutical for Endometriosis Pain Relief
Lead Sponsor:
Metagenics Europe
Conditions:
Endometriosis
Eligibility:
FEMALE
18-49 years
Phase:
NA
Brief Summary
Based on the EHP-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. These patients will be taking continuous ...
Eligibility Criteria
Inclusion
- Confirmed endometriosis and/or Positive NMR
- 18-49y
- Mean pain score \>6 on the assessment of pelvic pain (Visual analogue scale)
- Not eligible for surgery in the coming 3 months or had surgery \>3 months before inclusion in the study
- \>3 months intake of continue oral contraception (Oestrogen/Progesterone) before inclusion or no intake of oral contraception due to contraindication
- Has given voluntary, written, informed consent to participate in the study.
Exclusion
- Planned surgery during study
- \<3 month intake of continue oral contraception (Oestrogen/Progesterone) before inclusion
- Chronic inflammatory disease (Chron's disease, Rheumatism,..)
- Pregnancy
- Bariatric surgery
- Malabsorption issues
- Allergy or hypersensitivity to the study product:
- Fish and products thereof: fish oil
- Soybeans and products thereof
- Alcohol or substance abuse
- Start of gonadorelin analogue (ex. Busereline, Gosereline, triptoreline) therapy in the past 6 months
- Intake of other food supplements, including omega 3 and omega 6
- Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Key Trial Info
Start Date :
October 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04091191
Start Date
October 13 2021
End Date
December 16 2022
Last Update
March 16 2023
Active Locations (1)
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1
CHU Ambroise Paré de Mons
Mons, Hainout, Belgium, 7000