Drug intelligence / Profile preview

estradiol + progesterone (Vrije Universiteit Amsterdam)

Development stage
Unknown
Lead developer
TherapeuticsMD
Modality
Small Molecules
Administration
Transdermal, Oral
01

Overview

This specific intervention refers to the combination of transdermal estradiol and oral micronized progesterone investigated in the 'Sleeping Through Menopause' clinical trial conducted by the VU University of Amsterdam (Amsterdam UMC). The regimen consists of a transdermal patch (Systen 50) providing a stable release of 50 mcg of estradiol, combined with 200 mg oral progesterone capsules (Utrogestan) adjusted to the menstrual cycle. Estradiol acts as an agonist at estrogen receptors to alleviate climacteric symptoms like hot flashes and stabilize hormonal fluctuations during perimenopause. Progesterone is included to protect the endometrium from hyperplasia and may provide additional sedative effects via its metabolites' interaction with GABAergic pathways. The trial evaluates this hormone therapy individually and in combination with Cognitive Behavioral Therapy for Insomnia (CBT-i) to determine the most effective treatment for sleep disturbances and mood changes in perimenopausal women.

Brand names
SystenUtrogestan
Other names
estradiol-VU University of Amsterdam-insomnia-menopauseMenopausal Hormone TherapyMHTHormone Replacement TherapyHRTSleeping Through Menopause study intervention
02

Targets

PR (Progesterone receptor)ESR2 (ERβ)GABRR (GABA-A receptor subunit rho)ESR1 (ERα)

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