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Compounds and their uses for alleviating menopause-associated symptoms

A symptom, composition technology, application in the field of compounds and their use in alleviating menopause-related symptoms

Pending Publication Date: 2020-12-01
ESTETRA S P R L
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, it is a challenge to develop estrogens that are safer than those currently used

Method used

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  • Compounds and their uses for alleviating menopause-associated symptoms
  • Compounds and their uses for alleviating menopause-associated symptoms
  • Compounds and their uses for alleviating menopause-associated symptoms

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0171] Example 1 - Selection of a Daily Oral Dose of Estetrol (E4) for the Treatment of Vasomotor Symptoms in Postmenopausal Women Dose-Discovery Study

[0172] Study Registration and Duration:

[0173] The registration period is approximately 18 months. Individual subject participation up to 27 weeks: up to 6 weeks of pre-screening and washout; up to 4 weeks of screening and run-in period, up to 91 days (13 weeks) of E4 / placebo treatment, followed by 2 weeks (14 days) of progestin treatment, and a follow-up of 1 week after progestin treatment was completed only in non-hysterectomized subjects.

[0174] Main efficacy goals:

[0175] The minimum effective dose (MED) for oral doses of E4 was defined by assessing changes in the frequency and severity of moderate to severe vasomotor symptoms (VMS).

[0176] Methodology:

[0177] This is a prospective, multicenter, randomized, placebo-controlled, double-blind, dose-finding study.

[0178] Subject group:

[0179] Elig...

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Abstract

The present invention relates to a hormone replacement therapy, to the associated compounds and to the associated packaging units,for alleviating menopause-associated symptoms which is based on the administration to a female mammal of an estetrol component at specified daily doses, optionally in combination with a progestogenic component. The therapy enjoys a statistically significant efficacy combined with a favourable profile for side effects compared to currently available methods for alleviating menopause-associated symptoms.

Description

[0001] field of invention [0002] The present invention relates to hormone replacement therapy, related compounds and related packaging units for the relief of menopause-related symptoms, based on administering to a female mammal an estetrol component, optionally in combination with a progestogen component, in a specific daily dose. [0003] As described in further detail herein, the therapy demonstrated statistically significant efficacy and favorable side-effect profiles compared to currently available methods for alleviating menopause-related symptoms. Background technique [0004] Hormone replacement therapy (HRT) is used to describe the unopposed use of estrogen (for women who have had a hysterectomy) or combined estrogen-progestin therapy (for women who still have a uterus). The goal of HRT is to relieve menopausal symptoms, most importantly vasomotor symptoms (VMS), such as hot flashes. Other diseases and symptoms associated with perimenopause and menopause that respo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/565A61K31/55A61K31/57A61K31/585A61P5/30
CPCA61K31/55A61K31/565A61K31/57A61K31/585A61P5/30A61K2300/00A61P15/12A61K9/0053A61K31/573
Inventor M.塔齐奥克斯G.劳辛M.乔斯特M.马维特
Owner ESTETRA S P R L
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