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N-acetyl-l-cysteine for the treatment of endometriosis

A technology for endometriosis and cysteine, applied in the field of pharmaceutical compositions containing N-acetyl-L-cysteine, can solve the clinical results of endometriosis without a proposed dosage regimen Questions such as undecided

Inactive Publication Date: 2012-09-12
IASOMAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] To the best of the inventors' knowledge, the clinical outcomes of NAC in the treatment of endometriosis have not been established in the prior art, nor have there been indications for the treatment of endometriosis or the use of NAC in the treatment of endometriosis-related indications come up with an effective dosing regimen

Method used

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  • N-acetyl-l-cysteine for the treatment of endometriosis
  • N-acetyl-l-cysteine for the treatment of endometriosis
  • N-acetyl-l-cysteine for the treatment of endometriosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Example 1. Effects in a mouse model of endometriosis

[0095] Materials and methods

[0096] Material. All chemicals were from Sigma-Aldrich, Milan, Italy unless otherwise noted.

[0097] animal. Thirty-six female, 6- to 8-week-old BALB / C mice were purchased from Charles River Italia (Calco, Italy). Feed pellets (concentrated standard diet; Mucedola, Milan, Italy) and water were provided ad libitum. Animals were housed on a 16 / 8 hour light / dark cycle under controlled conditions. Before any invasive procedure, mice were anesthetized by intraperitoneal injection of 0.4 ml of a physiological solution containing 2.5% AVERTIN.

[0098] Induction of endometriosis. Induction of endometriosis was performed by the method published by Somigliana et al., Hum Reprod 1999 Dec; 14(12):2944-50. Perform surgical interventions under clean conditions. Briefly, the uterine horns of syngenic mice were removed through a small incision in the midline of the peritoneal space below the...

Embodiment 2

[0121] Example 2. Preclinical research on the effect of NAC in treating endometriosis

[0122] Research purposes. This pilot clinical study was designed to use NAC instead of other therapies for the treatment of women with endometriosis. The only possible additional treatment is analgesics for pain relief when needed.

[0123] Conditions for patient enrollment. Women with an initial diagnosis of endometriosis based on disease-based pain and ovarian ultrasound evidence, and patients with pain and / or ovarian endometrioma recurrence after laparoscopic treatment were enrolled in the study.

[0124] Before treatment, the intensity of pain symptoms was measured by means of a 10-point visual analog scale (VAS), and the characteristics of ovarian endometriomas were measured by ultrasound. During NAC treatment, other treatments were excluded except for pain management with analgesics when needed.

[0125] patient. From February 2008 to July 2010, 64 women diagnosed with ovarian en...

Embodiment 3

[0136] Example 3: Effect of Pulsed, Intermittent and Daily NAC Treatment on Experimentally Induced Endometriosis: A Pilot Study in Rats of Vaginal Hyperresponsiveness as a Sign of Pain

[0137] Materials and methods

[0138] animal. Sixteen virgin female Sprague-Dawley rats were used. They weighed 200-230 g at the beginning of the study and were housed in plastic cages with litter in a controlled room. Rats had ad libitum access to water and chow, and were kept on a 12-h light / dark cycle, with lighting starting at 07:00. Reproductive status (proestrus, estrus, postestrus, and diestrus) was determined by daily vaginal douching.

[0139] Experimental models and preoperative training. Prior to induction of endometriosis, rats were trained to develop an escape response to terminal vaginal dilatation by an inflatable latex balloon. A small, deflated latex balloon is tied to a thin, lubricated catheter and inserted into the midvaginal cavity. The balloon is inflated with air a...

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PUM

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Abstract

The invention relates to a new prescription of NAC in the treatment of endometriosisand of indications associated withendometriosis, in a human or mammalian animal patient. In addition an effective dose regimen of NAC in the treatment of endometriosis is proposed. In one embodiment of the present invention the prescribed treatment regimen may be used e.g. in order to control the frequency and the intensity of pain symptoms (dysmenorrhea, dyspareunia and acyclic chronic pelvic pain),to reduce the size of endometriotic lesions eventually up to their disappearance,to reduce recurrences after surgery and / or to improve fertility. Side effects of this treatment are virtually absent and, in particular, this treatment does not hinder pregnancy.

Description

field of invention [0001] The present invention relates to pharmaceutical compositions containing N-acetyl-L-cysteine ​​for the treatment of endometriosis and indications associated with endometriosis. Background technique [0002] Endometriosis is the third leading cause of gynecological hospitalizations in the United States and affects an estimated 14 million European women. Figures commonly used to represent the prevalence of endometriosis are 5-10% of all women of reproductive age and 30-40% of all women with infertility problems. The disease is characterized by the presence outside the uterine cavity of tissue structurally identical to the endometrium (the membrane that lines the uterus of mammals). This misplaced tissue develops into a growth or lesion (also called an implant or nodule) that responds to the menstrual cycle in the same way that endometrial tissue does: each month the tissue forms, breaks down and falls off. Blood flows out of the uterus during menstru...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61P15/00
CPCA61K9/0056A61K31/198A61K33/00A61K2300/00A61P15/00A61P25/00
Inventor T.帕拉萨西M.G.波尔波拉
Owner IASOMAI
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