Testosterone cypionate: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Testosterone cypionate appears in the FDA drug-label database. Marketed as Testosterone Cypionate.
FDA-approved use
Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL — Arbor Pharmaceuticals Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2019-09-27 |
| CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. — SUN PHARMACEUTICAL INDUSTRIES INC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-06-03 |
| cGMP - Water leakage — SUN PHARMACEUTICAL INDUSTRIES INC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-06-21 |
| cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot. — Sun Pharmaceutical Industries, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-01-14 |
| cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. — Eugia US LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-04-10 |
Phase breakdown
Conditions being studied
Recruiting trials involving Testosterone cypionate
- Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
- Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
- Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
- Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
- The COSMYC Trial (COmbined Suppression of MYC)
Common questions
Is Testosterone cypionate FDA-approved?
Yes, marketed as Testosterone Cypionate.
How many recruiting trials involve Testosterone cypionate?
6 recruiting trials across 7 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.