Testosterone Cypionate Dosing for Women with Hypo-Androgenism
Testosterone therapy in women is not FDA-approved and lacks robust evidence; however, when used off-label for documented hypo-androgenism in postmenopausal women with sexual dysfunction refractory to estrogen therapy, extremely low doses—typically 1–2 mg intramuscularly every 1–2 weeks or transdermal alternatives—are employed, with careful monitoring for virilization.
Evidence Base and Regulatory Status
No testosterone product is currently licensed for use in women in the United States or United Kingdom, and the European testosterone patch approved in 2006 for surgically menopausal women was withdrawn in 2012 for commercial reasons. 1
The North American Menopause Society (NAMS) position statement indicates that published randomized controlled trials—though limited—show that exogenous testosterone (both oral and non-oral formulations) has a positive effect on sexual function, primarily desire, arousal, and orgasmic response, in women after spontaneous or surgically induced menopause. 2
Data are inadequate to support testosterone use for any indication other than sexual dysfunction, including bone mineral density preservation, hot flash reduction, lean body mass increase, or general well-being improvement. 2
Candidate Selection and Diagnostic Criteria
Postmenopausal women with decreased sexual desire associated with personal distress and with no other identifiable cause may be candidates for testosterone therapy. 2
Before initiating therapy, rule out non-hormonal causes (physical and psychosocial factors, medications) and ensure a physiologic cause for reduced testosterone (e.g., bilateral oophorectomy). 2
Laboratory testing of testosterone levels should be used only to monitor for supraphysiologic levels before and during therapy, not to diagnose testosterone insufficiency, because clinically available assays do not accurately detect testosterone concentrations at the values typically found in women, and no testosterone level has been clearly linked to a clinical syndrome of hypoandrogenism. 2
Endogenous testosterone levels have not been clearly linked to sexual function in postmenopausal women, further limiting the utility of baseline testing for diagnosis. 2
Dosing Regimen for Intramuscular Testosterone Cypionate
Practical Off-Label Dosing
Women require approximately 1/50th to 1/100th of the male replacement dose to avoid virilization; therefore, typical off-label regimens use 1–2 mg of testosterone cypionate intramuscularly every 1–2 weeks. 2, 1
This dose is extrapolated from the principle that testosterone products formulated specifically for men have a risk of excessive dosing when used in women, and even lower doses of these products are employed by some clinicians. 2
Transdermal patches and topical gels or creams are preferred over oral products because of first-pass hepatic effects documented with oral formulations; however, no female-specific transdermal product is currently available in the U.S. 2
Monitoring and Dose Adjustment
Monitor serum testosterone levels 2–3 months after initiation to ensure levels remain within the normal female range and do not reach supraphysiologic concentrations. 2
Subjective assessments of sexual response, desire, and satisfaction should be performed at each visit, along with evaluation for potential adverse effects such as hirsutism and acne. 2
Administer testosterone at the lowest dose for the shortest time that meets treatment goals, and discontinue if no benefit is observed after 6 months. 2
Formulation Considerations
Custom-compounded products should be used with caution because dosing may be more inconsistent than with government-approved products. 2
Testosterone therapy without concomitant estrogen therapy cannot be recommended because of a lack of evidence; most trials have evaluated testosterone in combination with estrogen. 2
Transdermal testosterone gel (used off-label at very low doses, e.g., 1/10th of the male starting dose) may provide more stable day-to-day levels compared with injectable formulations. 3
Safety and Contraindications
Absolute Contraindications
- Testosterone therapy is contraindicated in women with breast or uterine cancer or in those with cardiovascular or liver disease. 2
Known Adverse Effects
Hirsutism and acne have been associated with testosterone therapy, but the actual risks are not well defined. 2
It is not known whether testosterone therapy increases the risk of breast cancer, cardiovascular disease, or thromboembolic events in women. 2
There are few data regarding the safety and efficacy of testosterone therapy in women not using concomitant estrogen therapy or for use longer than 6 months. 2
Clinical Algorithm for Initiating Therapy
Confirm postmenopausal status (spontaneous or surgical menopause). 2
Document decreased sexual desire with personal distress and rule out non-hormonal causes (relationship issues, medications, depression, physical illness). 2
Ensure concomitant estrogen therapy is in place (unless contraindicated), as testosterone monotherapy lacks supporting evidence. 2
Initiate testosterone cypionate 1–2 mg IM every 1–2 weeks or consider transdermal gel at 1/10th the male starting dose (e.g., 5 mg daily). 2, 3
Monitor testosterone levels at 2–3 months to confirm levels remain in the normal female range (typically 15–70 ng/dL). 2
Assess sexual function and adverse effects (hirsutism, acne, voice deepening) at each visit. 2
Discontinue therapy if no improvement after 6 months or if virilization occurs. 2
Common Pitfalls to Avoid
Do not use male-dose testosterone products without significant dose reduction, as this will cause virilization. 2
Do not rely on baseline testosterone levels to diagnose "testosterone deficiency" in women, as assays are inaccurate at female concentrations and no threshold has been validated. 2
Do not prescribe testosterone without concomitant estrogen unless estrogen is contraindicated, as the evidence base is limited to combination therapy. 2
Do not continue therapy beyond 6 months without documented benefit, as long-term safety data are lacking. 2
Do not use oral testosterone formulations due to first-pass hepatic effects; transdermal or injectable routes are preferred. 2