Evaluation of a Nutraceutical for Endometriosis Pain Relief

Metagenics

Status: Terminated

Conditions: Endometriosis

Treatments: Dietary Supplement: Meta19.01

Study type: Interventional

Funder types: Industry

Identifiers

NCT04091191

Meta19.01

Details and patient eligibility

About

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).

Enrollment: 5 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

Specialized nutraceutical

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Meta19.01

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Meta19.01