Clinical Trials

Multiple Phase 2 and Phase 3 clinical trials, primarily sponsored by Repros Therapeutics Inc. alongside Baylor College of Medicine, have evaluated enclomiphene citrate for male endocrine and metabolic conditions including secondary and acquired hypogonadotropic hypogonadism, low testosterone, obesity, male infertility, and bone mineral density. While a Phase 2 study investigating idiopathic male infertility was withdrawn, several studies evaluating morning testosterone normalization, body composition, and bone density have been completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02651688 COMPLETED
Acquired Hypogonadotropic Hypogonadism; Obesity
Repros Therapeutics Inc.
 2016-01-11 PHASE2
NCT02160704 WITHDRAWN
Infertility
Baylor College of Medicine
 2014-09-22 PHASE2; PHASE3
NCT01619683 COMPLETED
Effect of Treatment on Bone Mineral Density
Repros Therapeutics Inc.
 2012-09 PHASE3
NCT01739582 COMPLETED
Secondary Hypogonadism
Repros Therapeutics Inc.
 2012-11 PHASE3
NCT01534208 COMPLETED
Secondary Hypogonadism
Repros Therapeutics Inc.
 2012-05 PHASE3
NCT01739595 COMPLETED
Secondary Hypogonadism
Repros Therapeutics Inc.
 2012-11 PHASE3
NCT01386567 COMPLETED
Hypogonadism; Low Testosterone
Repros Therapeutics Inc.
 2011-07 PHASE2
NCT01386606 COMPLETED
Secondary Hypogonadism
Repros Therapeutics Inc.
 2011-06 PHASE2

(data from https://clinicaltrials.gov, updated on 2019-06-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enclomiphene citrate functions as a selective non-steroidal estrogen receptor antagonist that competitively binds to nuclear estrogen receptors in the hypothalamus, thereby blocking negative feedback inhibition mediated by endogenous estrogens and stimulating gonadotropin-releasing hormone release. This hypothalamic disinhibition restores pituitary secretion of luteinizing hormone and follicle-stimulating hormone, promoting testicular Leydig cell synthesis of endogenous testosterone to correct secondary hypogonadism and low testosterone levels.

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.