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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Endometriosis

Clinical Trial Details

NCT number	NCT02437175
Study type	Interventional
Source	Laboratoires Pronutri
Contact
Status	Completed
Phase	Phase 3
Start date	May 28, 2015
Completion date	December 31, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01931670` - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Recruiting	`NCT05648669` - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Completed	`NCT04665414` - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed	`NCT03690765` - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting	`NCT05153512` - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting	`NCT04171297` - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting	`NCT04172272` - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	N/A
Completed	`NCT04565470` - Strategies of Self-management of Endometriosis Symptoms
Completed	`NCT03613298` - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.	N/A
Withdrawn	`NCT05568940` - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting	`NCT03464799` - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting	`NCT03002870` - Characteristics of Patient Population With Endometriosis	N/A
Completed	`NCT02973854` - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn	`NCT03272360` - Endometriosis Biomarker Discovery Study	N/A
Recruiting	`NCT02481739` - Laparoscopic Surgical Management of Endometriosis on Fertility	N/A
Active, not recruiting	`NCT02754648` - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve	N/A
Completed	`NCT06106932` - GnRH-a on Angiogenesis of Endometriosis	N/A
Completed	`NCT02387931` - Supplementation in Adolescent Girls With Endometriosis	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms