Cyproterone Acetate Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4, early phase, and drug utilization studies have evaluated cyproterone acetate across completed, active, and terminated statuses. These investigations focus on female hyperandrogenic conditions—such as hirsutism, acne vulgaris, androgenetic alopecia, and polycystic ovary syndrome—alongside male indications including prostate cancer, hypersexuality, and sexual deviations. Supported by pharmaceutical sponsors like Bayer as well as academic medical institutions, evaluations of combination therapies and drug safety awareness highlight its broad therapeutic profile.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07714616	NOT_YET_RECRUITING	Contraception	Eurofarma Laboratorios S.A.	2027-05-31	PHASE3
NCT07513480	COMPLETED	PCOS	Mst.Sumyara Khatun	2024-08-12
NCT07145281	COMPLETED	Gender Dysphoria, Adult; Blood Coagulation; Coagulation Factors; Transgender Persons, M01.777.500; Hemostasis; Transgender Women	Tel-Aviv Sourasky Medical Center	2022-11-10
NCT04590417	ACTIVE_NOT_RECRUITING	Drug Interaction	Thai Red Cross AIDS Research Centre	2022-01-24
NCT04831151	UNKNOWN	Polycystic Ovary Syndrome	Inonu University	2021-03-01
NCT01973816	COMPLETED	Endometriosis	University Hospital, Rouen	2014-09-09	PHASE3
NCT03043924	COMPLETED	Polycystic Ovary Syndrome	University Hospital, Lille	2017-09-26
NCT04925180	Completed	Signs of Androgenisation in Women e.g. Hirsutism Androgenetic Alopecia Acne and Seborrhea\|Hypersexuality in Men\|Sexual Deviations in Men\|Prostate Cancer	Bayer	2021-10-18	--
NCT02715232	UNKNOWN	Gender Dysphoria	Medical University of Vienna	2017-02-06	PHASE4
NCT04848181	COMPLETED	Prostate Hyperplasia	Benha University	2019-07-01	EARLY_PHASE1
NCT02460445	COMPLETED	Hyperandrogenism; Metabolic Cardiovascular Syndrome	Manuel Luque Ramírez	2015-01
NCT04964193	COMPLETED	Drug Use	PT Sydna Farma	2019-03-12
NCT02689843	COMPLETED	Polycystic Ovary Syndrome	Shiraz University of Medical Sciences	2018-02-01	EARLY_PHASE1
NCT02744131	UNKNOWN	Polycystic Ovary Syndrome	Kar Clinic & Hospital Pvt. Ltd.	2016-05
NCT03236740	COMPLETED	PCOS	S.C.B. Medical College and Hospital	2017-08-01	PHASE4
NCT02729545	COMPLETED	Polycystic Ovarian Syndrome	Beijing Hospital of Integrated Traditional Chinese and Western Medicine	2016-04	PHASE2
NCT02866786	COMPLETED	Polycystic Ovary Syndrome	S.C.B. Medical College and Hospital	2016-08-15	PHASE4
NCT02027337	UNKNOWN	Polycystic Ovarian Syndrome; Hyperandrogenism; Menstrual Irregularities	Tyumen State Medical Academy	2013-12	PHASE4
NCT02494297	Completed	Hirsutism\|Androgenetic Alopecia\|Severe Anemia\|Seborrhea\|PCOS	Center for Epidemiology and Health Research Germany\|Bayer	2015-03-06	--
NCT01065220	COMPLETED	Transsexualism	Medical University of Vienna	2010-02	PHASE4
NCT01573377	COMPLETED	Polycystic Ovary Syndrome; Insulin Resistance	Chongqing Medical University	2012-02
NCT01103518	UNKNOWN	Amenorrhea; Dysmenorrhea; Menstruation Disturbances; Hyperandrogenism	Fundação Educacional Serra dos Órgãos	2009-12	PHASE4
NCT00003653	COMPLETED	Prostate Cancer	NCIC Clinical Trials Group	1999-01-05	PHASE3
NCT00601276	TERMINATED	Pedophilia	Institut National de la Santé Et de la Recherche Médicale, France	2007-12	PHASE3
NCT00196339	COMPLETED	Prostate Cancer	Duramed Research	2005-06	PHASE2
NCT01011751	COMPLETED	Adenocarcinoma, Prostate	Takeda	2004-04	PHASE3
NCT00955058	UNKNOWN	Polycystic Ovary Syndrome	Shahid Beheshti University	2007-02	PHASE2; PHASE3
NCT00849082	COMPLETED	Prostate Cancer	European Organisation for Research and Treatment of Cancer - EORTC	1987-05	PHASE3
NCT00363285	UNKNOWN	Prostate Cancer	St. Bartholomew's Hospital	2003-01	PHASE3
NCT00428311	COMPLETED	Polycystic Ovary Syndrome	Hospital Universitario Ramon y Cajal	2004-04	PHASE4
NCT00005623	COMPLETED	Hot Flashes; Prostate Cancer	Barr Laboratories	1999-12	PHASE3
NCT00752635	COMPLETED	Acne Vulgaris	Johnson & Johnson Taiwan Ltd	2004-09	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cyproterone acetate acts as a potent androgen receptor antagonist with an IC50 of 7.1 nM, competitively blocking endogenous androgen binding to suppress receptor nuclear translocation and downstream gene transcription. By inhibiting androgen-driven cell signaling and cellular proliferation, this compound effectively mitigates hyperandrogenic phenotypes, supporting its clinical evaluation for conditions such as prostate cancer, hirsutism, severe acne, and polycystic ovary syndrome.

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>).