Testosterone Therapy — Informed Consent & Patient Responsibility Agreement

Testosterone therapy may be prescribed as part of menopause or perimenopause care to help address symptoms such as low sexual desire, reduced energy, or decreased sense of well-being. The goal of therapy is symptom improvement using low, physiologic doses appropriate for women. I understand that individual response varies and that benefits are not guaranteed.

I understand that testosterone is not FDA-approved for use in women and that its use is considered off-label. I acknowledge that off-label prescribing is common in menopause care and may be supported by clinical evidence and expert consensus when prescribed and monitored appropriately.

I understand that some women may require up to six (6) months to experience meaningful improvement. I understand that if there is no meaningful benefit after this time, testosterone therapy may be discontinued. This approach is consistent with recommendations from expert consensus groups, including the Endocrine Society and the Global Consensus Position Statement on Testosterone Therapy for Women.

The strongest evidence supports testosterone for low sexual desire that causes distress, and many women also report improved arousal and sexual satisfaction. Evidence for other benefits — energy, mental clarity, mood, or overall sense of well-being — is limited, and clinical trials for mood and general well-being have not shown benefit. When testosterone is prescribed primarily for these other symptoms, it is a time-limited trial: my starting point is recorded, my response is reviewed at approximately 12 weeks, and treatment is discontinued if it is not helping. I understand benefits are not guaranteed and vary between individuals.

I understand that side effects are uncommon when testosterone levels are maintained within the female physiologic range, but potential risks may include: Acne or oily skin; Increased facial or body hair; Scalp hair shedding or thinning; Mood changes or irritability; Changes in cholesterol or liver markers. I understand that voice changes and clitoral enlargement are rare but may be irreversible. I acknowledge that these risks are dose-dependent and related to elevated testosterone levels, which is why appropriate dosing and regular laboratory monitoring are essential. I agree to report concerning symptoms promptly so that dose adjustments can be made early if needed.

I understand that testosterone therapy does not include or replace routine preventive health screenings, including mammograms. I understand that The Menopause Clinic does not track, schedule, or monitor my preventive screening compliance, and bears no responsibility for missed or overdue screenings. I understand that ongoing preventive care is my responsibility in coordination with my primary care provider or gynecologist. If I request a mammogram order from The Menopause Clinic, I understand this is provided solely as a convenience and does not establish an ongoing obligation, monitoring relationship, or shared liability for my preventive care.

Testosterone must not be used during pregnancy: it can cause harm to a developing female fetus. If I could become pregnant, I agree to use reliable contraception during treatment. I agree to notify my provider immediately if I become pregnant or believe I may be. I understand that the clinical trials supporting testosterone therapy were conducted in postmenopausal women, and evidence in perimenopause is limited.

I understand that: Testosterone is prescribed at low, physiologic doses; Dose adjustments are based on symptoms, laboratory results, and side effects; Baseline and periodic laboratory monitoring may be required; Therapy may be adjusted, paused, or discontinued if safety concerns arise; Failure to complete required monitoring may result in interruption or discontinuation of therapy.

I understand that testosterone therapy for women is typically not covered by insurance and is paid for out of pocket. I understand that pharmacy pricing and availability vary. I acknowledge that testosterone is a Schedule III controlled substance, that prescriptions cannot be transferred, and that only one electronic prescription may be issued per prescription period.

I understand that because testosterone is a controlled substance: Medication must be taken only as prescribed; Early refill requests may not be approved; Lost or stolen medication may not be replaced.

I understand that an in-person visit prior to refills and/or identity verification is required to continue testosterone therapy. This visit is required for regulatory compliance and patient safety.

I understand that alternative treatment options have been discussed and may include estrogen therapy, vaginal estrogen, non-hormonal therapies, lifestyle approaches, or choosing no treatment. I am choosing to proceed voluntarily.

I understand that choosing not to start testosterone therapy may result in continued or worsening symptoms, including low sexual desire, reduced arousal, decreased energy, reduced motivation, or diminished sense of well-being. I understand that untreated symptoms may continue to impact quality of life, relationships, mood, or overall functioning. I acknowledge that declining testosterone therapy does not pose immediate medical danger, but that symptoms may persist or progress. I understand that treatment decisions are individualized and that I may choose to revisit this decision in the future.

I understand that ongoing testosterone therapy requires an active clinical relationship with the practice. If my membership is canceled, lapses, or otherwise becomes inactive, I understand that my provider may be unable to continue prescribing testosterone due to the need for ongoing monitoring, follow-up, and regulatory requirements. I understand that if my membership status changes, I may need to re-establish care and complete required evaluations before testosterone therapy can be resumed.

I understand that safe and effective testosterone therapy requires shared responsibility. By continuing treatment, I agree that: I will use testosterone only as prescribed and will not change my dose, frequency, or method of use without provider approval; I will not share this medication or use testosterone obtained from another provider or source; I will complete required laboratory monitoring and visits; I will promptly report side effects or concerning symptoms, including voice changes, hair changes, acne, or mood changes; I will complete any required annual in-person visit or identity verification; I will communicate through the patient portal and respond to requests related to medication safety, monitoring, or compliance. I understand that reminders for labs, visits, or follow-up may be provided as a courtesy and that I am ultimately responsible for completing required monitoring on time. If requirements are not met, therapy may be paused or discontinued.