Segesterone acetate Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials evaluate segesterone acetate for reproductive health and male contraception, focusing on gonadotropin suppression, product transference, and daily transdermal combination gels. Sponsored by major academic institutions and research organizations—including the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development—these Phase I and Phase II studies include completed early-phase evaluations and an active, non-recruiting trial assessing male fertility control.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03452111	Active not recruiting	Healthy\|Men\|Male Contraception	Health Decisions\|Population Council\|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2018-10-25	Phase 2
NCT02994602	Completed	Healthy Men\|Male Contraception\|Healthy Women\|Product Transference	Health Decisions\|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)\|Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center\|University of Washington\|Population Council	2017-01	Phase 1
NCT00891228	Completed	Contraception	Health Decisions\|Population Council\|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2009-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Segesterone acetate functions as a synthetic progestin that selectively binds the progesterone receptor with an EC50 of 50.3 nM, thereby downregulating the hypothalamic-pituitary-gonadal axis and suppressing gonadotropin release. This biological cascade blocks ovulation in females and arrests spermatogenesis in males, underlying its therapeutic application in clinical trials for male and female contraception.

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>).