Should a pregnancy test be obtained before starting testosterone therapy in a patient assigned female at birth who could be pregnant?

Should a Pregnancy Test Be Done Prior to Testosterone Therapy?

Yes, a pregnancy test should be obtained before starting testosterone therapy in any patient assigned female at birth who has reproductive capacity, as testosterone is teratogenic and pregnancy can occur even in those on testosterone or with amenorrhea.

Rationale and Clinical Approach

Teratogenicity and FDA Labeling

Testosterone is classified as Pregnancy Category X by the FDA, meaning it is contraindicated in pregnancy 1. The drug label explicitly states testosterone cypionate should not be used in pregnancy due to teratogenic effects 1. This represents the highest level of contraindication for use during pregnancy and mandates pregnancy exclusion before initiation.

Testosterone Is Not Contraception

A critical misconception exists among both patients and some providers that testosterone provides contraceptive protection. Testosterone does not reliably prevent pregnancy 2. Key evidence includes:

• In one study, 16.4% of transgender men believed testosterone was contraception, and 5.5% reported their healthcare providers incorrectly advised them that testosterone functions as contraception 2
• Multiple documented cases exist of unplanned pregnancies occurring during testosterone therapy 3, 4
• Pregnancies have been reported even after years of testosterone use and amenorrhea 4, 2
• Of 60 pregnancies reported in one cohort, 17% occurred after stopping testosterone and 1.6% occurred while taking testosterone irregularly 2

Clinical Consequences of Missed Pregnancy

The 2025 case report highlights the severe consequences of failing to screen for pregnancy: a transgender patient on testosterone for gender affirmation was found to have a pregnancy at 35 weeks gestation after rising estradiol levels triggered evaluation for an endocrine tumor 3. The patient had resumed testosterone without pregnancy screening, resulting in prolonged fetal androgen exposure requiring long-term monitoring 4.

Practical Implementation

Before initiating testosterone:

1. Obtain a pregnancy test (urine or serum beta-hCG) for all patients assigned female at birth with reproductive organs who could potentially be pregnant
2. Consider offering serum testing rather than urine collection, as this may reduce gender dysphoria for some patients 5
3. Counsel explicitly that testosterone is not contraception and discuss contraceptive options 2
4. Document sexual activity, contraceptive use, and fertility intentions
5. Discuss fertility preservation options, as testosterone impacts reproductive capacity 6, 7

During testosterone therapy:

• Provide ongoing contraceptive counseling, as pregnancy risk persists 2, 8
• Be aware that over half of pregnancies in transgender men may be unintended 8
• Consider pregnancy testing if there are any clinical signs or if testosterone is temporarily discontinued

Common Pitfalls to Avoid

1. Assuming amenorrhea equals infertility: Menstrual suppression from testosterone does not guarantee inability to conceive 4, 2
2. Failing to address dysphoria around testing: Frame pregnancy testing as standard medical safety rather than questioning gender identity; offer serum testing as an alternative to urine collection 5
3. Inadequate contraceptive counseling: Explicitly state that testosterone is not birth control and discuss appropriate contraceptive methods 2
4. Truncating initial visits: Comprehensive sexual health and family planning discussions should not be deferred, even when patients are eager to start testosterone 3

Supporting Evidence from Guidelines

While the AUA guidelines on testosterone deficiency focus primarily on cisgender men and emphasize fertility counseling 9, the principles of excluding pregnancy before initiating teratogenic therapy are universal medical standards. The FDA labeling provides the definitive contraindication 1. The Mayo Clinic guideline on transgender care specifically addresses the dysphoria-inducing nature of pregnancy testing and recommends sensitive approaches 5.

The evidence is clear: pregnancy testing is a non-negotiable safety measure before initiating testosterone therapy in any patient with reproductive capacity, regardless of gender identity, menstrual status, or reported sexual activity.