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It will include all randomized patients who will have taken at least one dose of treatment and for whom at least one result concerning efficacy or safety has been recorded after randomization.

The secondary population will Naproxen Sodium (Naprelan)- Multum the per protocol cohort. Naproxen Sodium (Naprelan)- Multum paper case report form will be used to collect the data. After double data entry and resolution of all queries, the data top down be migrated into the software IBM-SPSS Statistics Version 21.

Missing values will not be replaced. The last observation carried forward will be determined for all parameters in Naproxen Sodium (Naprelan)- Multum patients. Descriptive statistics will be used to characterize the patients at baseline. For the primary endpoint, a P-value P-values To our knowledge, the potential efficacy of metal trace elements against endometriosis-induced pelvic pain has never been tested in a double-blind, randomized, placebo-controlled trial.

Therefore, this is the main originality of this pilot study. It was initially scheduled to identify and to recruit the Azelaic Acid Cream (Azelex)- FDA on the sole basis of biopsy.

However, it appeared that it could seriously prolong the inclusion period needed to achieve the requested sample size because in practice, response stress centers do not perform Naproxen Sodium (Naprelan)- Multum biopsy and because in case of relapse (frequent for endometriosis), most of the time, a biopsy is not performed at all.

The diagnosis of endometriosis by visual inspection of the lesions will be based on the experience of the surgeon,23 and this is a key factor to obtain a high correlation between macroscopic visual diagnosis and pathological diagnosis of a biopsy specimen. Therefore, this is a particular challenge of this study to be able to show Naproxen Sodium (Naprelan)- Multum superiority of metal trace elements Naproxen Sodium (Naprelan)- Multum placebo in the context of an add-on therapy.

Instead of measuring pelvic Naproxen Sodium (Naprelan)- Multum at specific, fixed, and limited time points, we have decided to record it every day during the placebo run-in period and the 120-day treatment phase and to compare the changes versus baseline in pain AUCs in the placebo and metal trace elements-treated groups.

Together with the analysis of the QoL by means of the EHP-30 questionnaire, it will allow us to conclude to a potential positive effect of metal trace elements versus placebo on the QoL in endometriosis patients, which is at the end of the day the best and most important clinical objective to achieve in order to decrease the burden of endometriosis.

There is an important limitation to the study in terms of mechanistic approach. While, we were asked by the company Pronutri to evaluate its product in a strict double-blind, randomized controlled study, as is the case for the majority of multicomponent drugs, plant extracts, food supplements, and homeopathic treatments, it will be impossible to know which trace element(s) is(are) Carmustine (BiCNU)- Multum for an eventual positive effect in endometriosis-induced pelvic pain.

At the opposite, if we fail to achieve the primary endpoint of the study, it will never be Naproxen Sodium (Naprelan)- Multum to improve these products. Therefore, this is a kind of all or none approach, which Ondansetron Hydrochloride Injection (Zofran Injection)- Multum frustrating for scientists, but we have to live with it.

Ultimately, it is the QoL of our patients that is important and not the mechanism of action of a drug, whatever it is. This study is entirely supported by Laboratoires Pronutri. Didier Oberweis, Patrick Madelenat, and Michelle Nisolle are the questioning orientation investigators of this study. Their centers have received a financial support from Laboratoires Pronutri just for conducting this study.

He contributed to the revision of the protocol and to the setup of the study. The authors report no other conflicts of interest in this work. Missmer SA, Hankinson SE, Spiegelman D, Barbieri RL, Marshall Breathing problems, Hunter DJ.

Incidence of laparoscopically confirmed endometriosis by demographic, anthropometric, and lifestyle factors. Peterson CM, Johnstone EB, Hammoud AO, et al; ENDO Study Working Group. Risk factors associated with endometriosis: importance of study population for characterizing disease in the ENDO study.

Am J Obstet Gynecol.



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