Clinical Trials

Multiple clinical trials evaluate estriol across conditions including dyspareunia, menopause, sexual dysfunction, hormone disturbances, preterm birth, and quality of life during pregnancy. Conducted by academic and private sponsors, these studies encompass Phase 1, Phase 2, and non-applicable phase designations, with recruitment statuses spanning recruiting, completed, and unknown. Additionally, a clinical trial specifically investigates topical estriol administration for relieving postmenopausal coital pain and vaginal discomfort.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05000424 Unknown status
Quality of Life|Pregnancy Related
Franklin Health Research
 2021-11-01 Not Applicable
NCT05012072 Recruiting
Mental Health Wellness 1|Preterm Birth
Microgen LLC
 2021-08-01 Phase 2
NCT04305093 Completed
Obesity; Endocrine|Hormone Disturbance
Precision Analytical Inc.
 2019-12-15 --
NCT04267731 Completed
Aging Well
Vemico Ltd.|University of Roehampton
 2019-12-01 Not Applicable
NCT03116022 Unknown status
Dyspareunia|Menopause|Sexual Dysfunction
University of Sao Paulo
 2017-06-01 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Estriol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Estriol selectively binds to the G-protein coupled estrogen receptor, antagonizing GPER-mediated signal transduction pathways and downregulating intracellular signaling cascades in target cells. By inhibiting receptor-mediated downstream activation and modulating cellular responses, estriol prevents aberrant cell proliferation while exhibiting clinical utility in managing hormone disturbances and menopausal conditions such as dyspareunia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.