Evaluation of a Nutraceutical for Endometriosis Pain Relief

NCT04091191 | Terminated

• 1 other identifier: Meta19.01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inflammation marker C-reactive protein (CRP)

  3 months

• General well-being

  3 months

• The need for analgesics

  3 months

Study Arms (2)

Specialized nutraceutical

ACTIVE COMPARATOR

Specialized nutraceutical formulated in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.

Dietary Supplement: Meta19.01

Placebo

PLACEBO COMPARATOR

Identical placebo formulated without active ingredients in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.

Dietary Supplement: Meta19.01

Interventions

Meta19.01 DIETARY_SUPPLEMENT

A specialized nutraceutical containing plant extracts, vitamins and fish oil

Placebo; Specialized nutraceutical

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed endometriosis and/or Positive NMR
• Mean pain score \>6 on the assessment of pelvic pain (Visual analogue scale)
• Has given voluntary, written, informed consent to participate in the study.

You may not qualify if:

• Planned surgery during study
• 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

Sponsors & Collaborators

• Metagenics Europe: lead

Study Sites (1)

CHU Ambroise Paré de Mons

Mons, Hainout, 7000, Belgium

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yaacoub Salame, MD

  CHU Ambroise Paré de Mons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: October 13, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)