Drug intelligence / Profile preview

estrogen + probiotics

Development stage
Unknown
Lead developer
Ghent University Hospital
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Small Molecules, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Topical
01

Overview

Estrogen + probiotics is a combination therapy being investigated by the University Hospital, Ghent, specifically for the treatment of vulvovaginal atrophy (VVA) in breast cancer patients receiving endocrine therapy. This treatment is administered as a vaginal ovule and is one of four arms in the Phase 4 GRACE trial. The combination aims to address the symptoms of VVA—a common side effect of selective estrogen-receptor modulators (SERMs) or aromatase inhibitors—by using estrogen to restore the vaginal epithelium and probiotics to replenish the vaginal microbiome and maintain a healthy vaginal pH. The trial evaluates efficacy through patient-reported outcomes, vaginal pH, and the vaginal maturation index, while monitoring safety via systemic sex hormone levels.

Other names
oestrogen plus probioticsestrogen and probioticsestrogen + probiotics-University Hospital, Ghent
02

Targets

ESR1 (ERα)ESR2 (ERβ)

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