Clinical Trials

Clomifene citrate has been evaluated across multiple Phase III and Phase IV clinical trials focusing on reproductive health disorders, including female infertility, subfertility, polycystic ovary syndrome, insulin resistance, and nonobstructive azoospermia. Sponsored predominantly by academic institutions and medical centers, these trials assess the drug's comparative clinical efficacy in ovulation induction and hormonal stimulation protocols. The collective research encompasses completed, unknown, and withdrawn recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03615547 WITHDRAWN
Azoospermia, Nonobstructive
Hospices Civils de Lyon
 2026-01 PHASE3
NCT02647424 UNKNOWN
Polycystic Ovarian Syndrome; Subfertility
The University of Hong Kong
 2015-12
NCT02544776 COMPLETED
Female Infertility Associated With Anovulation
Ahmed Fathy Ali Mohamed Ghanem
 2015-01
NCT00478504 COMPLETED
Infertility; Polycystic Ovarian Syndrome
University of Nottingham
 2007-05 PHASE4
NCT01638988 WITHDRAWN
Polycystic Ovary Syndrome; Insulin Resistance
Clinique Ovo
 2013-09 PHASE3
NCT01791751 COMPLETED
Female Infertility
Fundació Privada Eugin
 2012-06 PHASE4
NCT01569945 COMPLETED
Subfertility
University Hospital, Gasthuisberg
 2004-09
NCT01389713 COMPLETED
Infertility
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
 2008-09

(data from https://clinicaltrials.gov, updated on 2026-06-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clomifene citrate functions as a selective estrogen receptor modulator that binds competitively to estrogen receptors in the hypothalamus, thereby blocking the negative feedback action of endogenous circulating estrogen. This hypothalamic inhibition triggers an increase in gonadotropin production and follicle-stimulating hormone secretion to promote ovarian follicular development, demonstrating primary therapeutic relevance for ovulation induction in patients with polycystic ovary syndrome and female infertility.

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.