Method for the management of dysmenorrhea and menstrual pain

a dysmenorrhea and menstrual pain technology, applied in the field of dysmenorrhea and menstrual pain management, can solve the problems of increased risk of undesirable side effects, increased risk of thromboembolism, nausea, etc., and achieve the reduction of the number, frequency and/or severity of breast pain events, and the number of headaches. and/or headaches. the effect of severity

Pending Publication Date: 2019-06-06
ESTETRA SRL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0026]In a further embodiment of the invention, the number, frequency and/or severity of headaches is reduced, compared to other dysmenorrhea treatments of similar efficacy.
[0027

Problems solved by technology

The pain is usually crampy and intermittently intense, but may be a continuous dull ache.
Although the pain is usually strongest in the midline, some women also have severe back and/or thi

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0089]During that study, healthy female subjects were treated for one 28-day cycle with either 10 or 20 mg E4 alone (n=10 and 11, respectively) or with a combination of E4 with either Progesterone (P) or Desogestrel (DSG) (n=15 or 16, respectively).

[0090]At baseline, occasional dysmenorrhea was reported by 11 subjects (21.2%), and frequent dysmenorrhea was reported by 19 subjects (36.5%). The distribution of dysmenorrhea is shown in Table 2 below. Overall, dysmenorrhea was reported by 25% to 53.3% of the subjects included in this trial.

TABLE 2Reports at BaselineNumber (%) of subjects20 mg20 mg20 mg10 mg E4E4E4 / DSGE4 / P4Dysmenorrhea(n = 10)(n = 11)(n = 15)(n = 16)No4 (40.0)7 (63.6)5 (33.3)6 (37.5)Occasional2 (20.0)1 (9.1) 2 (13.3)6 (37.5)Frequent4 (40.0)3 (27.3)8 (53.3)4 (25.0)Total number of6 (60.0)4 (36.4)10 (66.7) 10 (62.5) subjects presentingdysmenorrhea atbaseline

[0091]As shown in Table 3 of Treatment-emergent adverse events (TE-AE) below, reporting of dysmenorrhea during the tre...

example 2

[0092]In this clinical study comparing different doses and different combinations of estrogenic components and progestogenic components according to the invention, overall, at baseline, 68.9% of subjects had previously experienced dysmenorrhea, which was occasional in 40.4% of subjects and frequent in 28.5% of subjects.

[0093]As illustrated in Table 4 below extracted from Treatment-emergent adverse events (TE-AE) reported by at least 2 subjects in any treatment group, dysmenorrhea was more rarely reported when the progestogenic component was drospirenone than when it was levonorgestrel.

[0094]Additionally, and quite surprisingly, it is also seen in Table 4 that the lowest dose of the estrogenic component (15 mg daily) leads to fewer reports of dysmenorrhea as TE-AE than the higher dose (20 mg daily).

TABLE 4Treatment-emergent adverse eventsNumber (%) of subjects20 mg E4 / 20 mg E4 / 15 mg E4 / 15 mg E4 / 150 μg LNG3 mg DRSP150 μg LNG3 mg DRSPTE-AE(n = 77)(n = 75)(n = 80)(n = 79)Dysmenorrhea5 (...

example 3

[0096]In this clinical study comparing the combination of estrogenic component and progestogenic component according to the invention with a commercially available contraceptive treatment using also a natural estrogen (estradiol valerate at a 1, 2 or 3 mg dose of with dienogest at a dose of 0, 2 or 3 mg, marketed as Qlaira ® by Bayer HealthCare, Germany), the number of drug-related adverse events (Treatment-emergent adverse events (TE-AE) reported by at least 2 subjects in any treatment group) and the levels of the SHBG marker were monitored.

[0097]As illustrated in Table 5 below, 13 subjects (corresponding to 16.7%) reported TE-AEs related to headache in the treatment arm with the commercial product based on estradiol valerate and dienogest, while only 6 subjects (corresponding to 7.6%) did so in the group treated with a combination of 15 mg of estetrol and 3 mg of drospirenone. The number of events related to headache was thus shown to be much lower for the treatment according to t...

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PUM

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Abstract

The present invention relates to a method for the management of dysmenorrhea involving administration of an estrogenic component which is preferably selected from the group consisting of estetrol and estetrol-like compounds. Estetrol-like compounds have been surprisingly found to be capable of mitigating dysmenorrhea, either when used alone or in combination with progestogenic components, and this to an extent surpassing the effect obtained with other compositions and with a favourable side-effect profile compared to currently available methods.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a method of alleviating the symptoms of dysmenorrhea in a person, comprising administering to said person an effective amount of an estrogenic component. More particularly the estrogenic component is an estetrol component, as further defined herein, and the method enjoys a favourable side-effect profile compared to currently available methods.BACKGROUND ART[0002]Dysmenorrhea is a medical condition characterized by the presence of recurrent, crampy, lower abdominal pain that occurs during menses. Most women begin having dysmenorrhea during adolescence, usually within four to five years of the first menstrual period. Painful periods become less common as women age. For clinical purposes, dysmenorrhea is divided into two broad categories, primary and secondary dysmenorrhea. Primary dysmenorrhea refers to the presence of recurrent, crampy, lower abdominal pain that occurs during menses in the absence of demonstrable disease th...

Claims

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Application Information

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IPC IPC(8): A61K31/585A61P15/00A61K31/566
CPCA61K31/585A61P15/00A61K31/566A61K31/565A61K2300/00A61P15/18
Inventor JOST, MAUDRAUSIN, GLWADYS
Owner ESTETRA SRL
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