Clinical Trials

Several clinical trials evaluate the therapeutic application and pharmacokinetics of ulipristal acetate across Phase 1 through Phase 4 and unassigned study designs. These investigations focus on reproductive and oncological conditions, including uterine fibroids, contraceptive-associated unscheduled bleeding, emergency contraception in obese populations, and breast cancer risk reduction. Sponsored by academic research centers, national health institutes, and pharmaceutical corporations, these studies are predominantly completed alongside a withdrawn trial entry.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03349190 Completed
Infertility Female|Fibroid Uterus
ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO|Gedeon Richter Plc.
 2017-12-29 --
NCT03118297 Completed
Contraception|Bleeding
Washington University School of Medicine
 2017-05-01 Phase 3
NCT03156127 Withdrawn
Uterine Myoma
Boryung Pharmaceutical Co. Ltd
 2017-05-19 Phase 1
NCT02859337 Completed
Obesity|Contraception
Oregon Health and Science University|National Institutes of Health (NIH)
 2017-05-30 Phase 4
NCT02408770 Completed
Breast Cancer
Manchester University NHS Foundation Trust|University of Manchester
 2016-01-22 Phase 2

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

Check the Ulipristal Acetate (CDB 2914) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ulipristal acetate functions as a selective progesterone receptor modulator that competitively binds to progesterone receptors, inhibiting progesterone-dependent gene transcription and downstream signal transduction. This receptor blockade suppresses ovulation and alters endometrial tissue dynamics, providing direct therapeutic efficacy for emergency contraception as well as the management of uterine fibroids and progesterone-sensitive tumors evaluated in clinical studies.

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.