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As a pregnancy Category X medication, Delatestryl (testosterone enanthate) should never be used during pregnancy. This drug increases the risk of masculinization of the genitals in female fetuses. If you have been exposed to this medication during pregnancy, let your healthcare provider know right away.

Is Delatestryl Safe for Pregnant Women?

Delatestryl® (testosterone enanthate) is a prescription medication given by injection. It contains testosterone and is not safe for use by pregnant women in any situation. Delatestryl is approved for women only for the treatment of certain cases of late-stage breast cancer.

What Is Pregnancy Category X?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in humans who have mistakenly taken the medicine.
When pregnant animals or women are exposed to androgens like Delatestryl, there is a definite risk of masculinization of the genitals in female fetuses. The risk for the most dramatic changes occurs with early first-trimester exposure, although exposure at any time during pregnancy can cause some genital changes.
Because it would be unethical to give Delatestryl to pregnant women, its use in pregnant women has never been studied in a clinical trial. However, we know about the problems the medication might cause based on problems seen with testosterone or other androgens given to pregnant animals and based on a few cases of testosterone exposure in pregnant women.

Final Thoughts

Using Delatestryl during pregnancy can cause severe genital defects in female fetuses. Therefore, you should not use this drug if you are or may become pregnant. It is important to let your healthcare provider know right away if you have used Delatestryl or been exposed to it during pregnancy.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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