17-Hydroxyprogesterone Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate therapeutic strategies for conditions associated with 17-hydroxyprogesterone, including classic and non-classic congenital adrenal hyperplasia, cardiovascular diseases, and hormone regulation. Spanning Phase 1, Phase 2, Phase 3, and unassigned phase protocols, these investigations are supported by research institutions such as Hospital Israelita Albert Einstein alongside pharmaceutical sponsors including Crinetics Pharmaceuticals Inc., H. Lundbeck A/S, and Diurnal Limited. Active studies in this portfolio are currently recruiting or enrolling participants by invitation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06402344	Recruiting	Hormones; Abuse\|Cardiovascular Diseases	Hospital Israelita Albert Einstein	2024-05-27	--
NCT05907291	Recruiting	Congenital Adrenal Hyperplasia\|Classic Congenital Adrenal Hyperplasia	Crinetics Pharmaceuticals Inc.	2023-07-03	Phase 2
NCT05669950	Recruiting	Congenital Adrenal Hyperplasia	H. Lundbeck A/S	2022-12-19	Phase 1
NCT05299554	Enrolling by invitation	Congenital Adrenal Hyperplasia	Diurnal Limited	2022-04-01	Phase 3

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

Check the 17-Hydroxyprogesterone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous progestogen and vital metabolic intermediate, 17-hydroxyprogesterone interacts with steroidogenic enzymes to regulate the downstream biochemical synthesis of corticosteroids, androgens, and estrogens. Proper control of this biosynthetic cascade modulates hormone-mediated cellular signaling, which is directly relevant to restoring physiological hormone balance in endocrine disorders such as congenital adrenal hyperplasia.

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>).