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Efficacy of Trace Elements in the Treatment of Endometriosis: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02437175
Recruitment Status : Unknown
Verified April 2017 by Laboratoires Pronutri.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2015
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Expert Clinical Services Organization (ECSOR)
Information provided by (Responsible Party):
Laboratoires Pronutri

Brief Summary:
The primary objective of this pilot study is to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain in endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months.

Condition or disease Intervention/treatment Phase
Endometriosis Dietary Supplement: ENDO 1/ENDO 2 Dietary Supplement: Placebo Phase 3

Detailed Description:

The objectives of this pilot study are to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain, on the quality of life, on the use of rescue medication (ibuprofen) in patients with an endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months. The safety of trace elements versus placebo will also be assessed.

This will be a prospective, interventional, randomized, placebo-controlled, two parallel-group, double-blind study.

Trace elements or placebo are administered in the absence of any other treatment or as add-on treatments to common therapies such as sexual hormones, anti-inflammatory drugs or surgery.

A run-in placebo period of 30 days will allow eliminating the patients who are responding to strongly to a placebo.

The treatment will last for 4 months. The total duration of the study will be 5 months for each patient. Four medical visits (Days -45 to -30, 0, 60 and 120) and two phone contacts (Days 30 and 90) will be scheduled.

A urine pregnancy test will be undertaken at each visit. The quality of life scale (EHP-30) will be filled in on Days 0, 60 and 120. During the whole study period, patients will be asked to fill in a diary, in which they will score their pain on a visual analog scale, their blood loss and their consumption of rescue medication (ibuprofen).

Phone contacts will be used to reinforce the compliance and to collect potential adverse events.

Non-serious and serious adverse events will be collected between Days 0 and 120.

All concomitant medications will be recorded, including the rescue medication between Day -45 and Day 120.

A paper case report form will be used.

A total of 60 patients (30 receiving trace elements and 30 receiving placebo) will be randomized to achieve a total of 50 patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Food Supplements Containing Trace Elements in the Treatment of Endometriosis, Combined or Not to an Adenomyosis: a Pilot Study
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.
Dietary Supplement: Placebo
Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.

Experimental: Trace elements
NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days.
Dietary Supplement: ENDO 1/ENDO 2
NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days.




Primary Outcome Measures :
  1. Pain (visual analog scale) [ Time Frame: Day 0 to Day 120 ]
    Pain scored daily by the patient using a visual analog scale


Secondary Outcome Measures :
  1. EHP-30 (validated 30-items questionnaire) [ Time Frame: Day 0 to Day 120 ]
    Quality of life determined using a validated 30-items questionnaire (EHP-30)

  2. Rescue medication consumption (Number of ibuprofen tablets consumed) [ Time Frame: Day 0 to Day 120 ]
  3. Safety (Non-serious and serious adverse events (related or not) [ Time Frame: Day 0 to Day 120 ]
    Non-serious and serious adverse events (related or not)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Woman suffering from an AFSr 2 to 4 endometriosis (combined or not to an adenomyosis), confirmed by laparoscopy, laparotomy or MRI as well as by a biopsy (done within 3 years before inclusion in the study), treated or not with sexual hormones, contraceptive or not (stable treatment for minimum 2 months) or any other treatment
  • Time period of at least 6 months after surgical treatment
  • Age between 18 and 45 years
  • Non-menopausal woman
  • Baseline pain (Day -45 to -30) of at least 40 mm on a visual analog scale
  • No reduction of more than 20% of pain on the visual analog scale after the run-in placebo period.

Exclusion Criteria:

  • AFSr 1 endometriosis
  • Adenomyosis without endometriosis
  • Pregnancy
  • Existence of another pathology that could interfere with endometriosis and/or with adenomyosis, and the study follow-up
  • Psychological or psychiatric conditions
  • Patient who, according to the investigator, will not be able to comply to the prerequisites of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437175


Locations
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Belgium
CHU Vésale
Montigny-le-Tilleul, Hainaut, Belgium, 6110
Sponsors and Collaborators
Laboratoires Pronutri
Expert Clinical Services Organization (ECSOR)
Investigators
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Principal Investigator: Didier Oberweis, MD CHU Vésale

Additional Information:
Study Data/Documents: Methodology paper  This link exits the ClinicalTrials.gov site

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Responsible Party: Laboratoires Pronutri
ClinicalTrials.gov Identifier: NCT02437175     History of Changes
Other Study ID Numbers: Pronutri-IIIa-001
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2017

Keywords provided by Laboratoires Pronutri:
pelvic pain
quality of life
adenomyosis

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs