Testosterone Undecanoate (TU)

Alternative Name: TU; Aveed

Description: Testosterone undecanoate (TU) is manufactured by Bayer Health Care and the injectable formulation was recently approved by the FDA (Aveed) to be marketed by Endo Pharmaceuticals for treatment of hypogonadism. It is not approved for use as a contraceptive agent.

Product Details

User: Male

Hormonal: Yes

Delivery Method: Injectable

Duration Type: Short-acting

Regimen:
  • Monthly injections

Dose: 500 mg

Active Pharmaceutical Ingredient (API):
  • testosterone undecanoate

Inactive material: tea seed oil

Multipurpose Preventive Technology (MPT): No

Status Details

Developer: Bayer HealthCare, National Research Institute for Family Planning in Beijing

Project Phase: Pre-Clinical and Clinical Development

Development Stage: Phase III

Active Development: No

Status Details:
  • A phase III trial was completed in China in 2008 by the National Research Institute for Family Planning.
  • In the Chinese study, TU was evaluated as a stand-alone contraceptive, but it is unlikely that further development will happen with it as as a single API product, but would rather be developed with a progestin added.

Additional Information

References:
  • Gu Y, Liang X, et al. (2009) Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men. J Clin Endocrinol Metab. 94(6): 1910-5.

Footnotes:
  • See also entries for TU with a progestin, such as TU + NET-EN

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