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

NCT02437175 | Completed Phase 3

• 1 other identifier: Pronutri-IIIa-001
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

pelvic pain; quality of life; adenomyosis

Outcome Measures

Primary Outcomes (1)

• Pain (visual analog scale)

  Pain scored daily by the patient using a visual analog scale

  Day 0 to Day 120

Secondary Outcomes (3)

• EHP-30 (validated 30-items questionnaire)

  Day 0 to Day 120

• Rescue medication consumption (Number of ibuprofen tablets consumed)

  Day 0 to Day 120

• Safety (Non-serious and serious adverse events (related or not)

  Day 0 to Day 120

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Trace elements

EXPERIMENTAL

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

Interventions

ENDO 1/ENDO 2 DIETARY_SUPPLEMENT

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.

Trace elements

Placebo DIETARY_SUPPLEMENT

Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoires Pronutri: lead
• Expert Clinical Services Organization (ECSOR): collaborator

Study Sites (1)

CHU Vésale

Montigny-le-Tilleul, Hainaut, 6110, Belgium

Location

Related Links

• A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Adenomyosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Diseases

Study Officials

• Didier Oberweis, MD

  CHU Vésale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 7, 2015
• Study Start: May 28, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

BE (1)