Evaluation of a Nutraceutical for Endometriosis Pain Relief

Study Overview
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Brief Summary
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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).

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

Conditions
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Endometriosis

Intervention / Treatment
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* Dietary Supplement: Meta19.01


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Specialized nutraceutical<br>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<br>* A specialized nutraceutical containing plant extracts, vitamins and fish oil<br>|
| Placebo Comparator: Placebo<br>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<br>* A specialized nutraceutical containing plant extracts, vitamins and fish oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |