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Evaluation of a Nutraceutical for Endometriosis Pain Relief

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04091191
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Information provided by (Responsible Party):
Metagenics Europe

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).

Condition or disease Intervention/treatment Phase
Endometriosis Dietary Supplement: Meta19.01 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: a Single Center, Randomized, Double-blind, Placebo Controlled Study to EVALUATE THE EFFICACY AND TOLERABILITY OF A SPECIALIZED NUTRACEUTICAL FOR ENDOMETRIOSIS
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Meta19.01
A specialized nutraceutical containing plant extracts, vitamins and fish oil

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

Primary Outcome Measures :
  1. Pain relief [ Time Frame: 3 months ]
    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.

Secondary Outcome Measures :
  1. Inflammation marker C-reactive protein (CRP) [ Time Frame: 3 months ]
    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.

  2. General well-being [ Time Frame: 3 months ]
    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. The need for analgesics [ Time Frame: 3 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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Responsible Party: Metagenics Europe Identifier: NCT04091191     History of Changes
Other Study ID Numbers: Meta19.01
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genital Diseases, Female