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Evaluation of a Nutraceutical for Endometriosis Pain Relief

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ClinicalTrials.gov Identifier: NCT04091191
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
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.



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

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Responsible Party: Metagenics Europe
ClinicalTrials.gov 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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Endometriosis
Genital Diseases, Female