Evaluation of a Nutraceutical for Endometriosis Pain Relief

Endometriosis Clinical Trial

Official title:

A Single Center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of a Specialized Nutraceutical for Endometriosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04091191
• Other study ID #: Meta19.01
• Status: Terminated
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: March 2023
• Source: Metagenics Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Dietary Supplement:
• Meta19.01
A specialized nutraceutical containing plant extracts, vitamins and fish oil

Locations

Country	Name	City	State
Belgium	CHU Ambroise Paré de Mons	Mons	Hainout

Sponsors (1)

Lead Sponsor	Collaborator
Metagenics Europe

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	pain relief monitored via the Assessment of Pelvic Pain (Visual Analogue scale, VAS) in the Endometriosis Health Profile 30 questions (EHP-30) at baseline and after 3 months of study product intake. The mean of all 3 VAS scales is taken to monitor the evolution of the pain of the subjects. Scores can be given from 0 to 10 with 0 as no pain and 10 as unbearable pain.	3 months
Secondary	Inflammation marker C-reactive protein (CRP)	CRP will be measured at baseline and after 3 months of study product intake. High CRP values (>3mg/L) indicate inflammation while low CRP values (<1 mg/L) indicate no inflammation.	3 months
Secondary	General well-being	The general well-being will be monitored via the Endometriosis Health Profile questionnaire with 30 questions (EHP-30) at baseline and after 3 months of product intake. These scales are transformed into a score from 0 to 100, in which 0 indicates a better health status, while 100 indicates a worse quality of life.	3 months
Secondary	The need for analgesics	The need for analgesics while taking the study product will be monitored via an analgesic diary completed every time the subject takes pain medication. Over 3 months, the total need for analgesics per month will be counted and compared inbetween both groups.	3 months