Evaluation of a Nutraceutical for Endometriosis Pain Relief

NCT ID: NCT04091191

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2022-12-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Specialized nutraceutical

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

Group Type: ACTIVE_COMPARATOR

Meta19.01

Intervention Type: DIETARY_SUPPLEMENT

A specialized nutraceutical containing plant extracts, vitamins and fish oil

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Meta19.01

Intervention Type: DIETARY_SUPPLEMENT

A specialized nutraceutical containing plant extracts, vitamins and fish oil

Interventions

Meta19.01

A specialized nutraceutical containing plant extracts, vitamins and fish oil

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Metagenics Europe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaacoub Salame, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Ambroise Paré de Mons

Locations

CHU Ambroise Paré de Mons

Mons, Hainout, Belgium

Countries

Belgium

Other Identifiers

Meta19.01

Identifier Type: -

Identifier Source: org_study_id