Overview

This trial is active, not recruiting.

Condition endometriosis
Treatments endo 1/endo 2, placebo
Phase phase 3
Sponsor Laboratoires Pronutri
Collaborator Expert Clinical Services Organization (ECSOR)
Start date May 2015
End date December 2016
Trial size 99 participants
Trial identifier NCT02437175, Pronutri-IIIa-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.
placebo
Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.
(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.
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 Outcomes

Measure
Pain (visual analog scale)
time frame: Day 0 to Day 120

Secondary Outcomes

Measure
EHP-30 (validated 30-items questionnaire)
time frame: Day 0 to Day 120
Rescue medication consumption (Number of ibuprofen tablets consumed)
time frame: Day 0 to Day 120
Safety (Non-serious and serious adverse events (related or not)
time frame: Day 0 to Day 120

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Efficacy of Food Supplements Containing Trace Elements in the Treatment of Endometriosis, Combined or Not to an Adenomyosis: a Pilot Study
Principal investigator Didier Oberweis, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Laboratoires Pronutri.