Is Kyzatrex (Sodium Oxybate) approved for use in women?

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From the Research

No, Kyzatrex cannot be used for women. Kyzatrex is a testosterone replacement therapy medication specifically approved by the FDA for adult men with hypogonadism (low testosterone) 1. It contains testosterone undecanoate, which is not appropriate for women as females naturally have much lower testosterone levels than men, and introducing high doses of testosterone can cause serious side effects in women including virilization (development of male characteristics like facial hair, deepening voice, and clitoral enlargement), menstrual irregularities, and potential cardiovascular issues.

The most recent and highest quality study on Kyzatrex, a phase III trial published in 2024, demonstrates its efficacy and safety in hypogonadal men, with 87.8% of participants achieving eugonadal mean plasma testosterone values 1. However, this study does not provide any evidence for the use of Kyzatrex in women.

Women who need hormonal treatment typically require different medications specifically designed for female hormonal needs. If a woman is experiencing symptoms that might seem related to hormone imbalance, she should consult with a healthcare provider who can recommend appropriate treatments designed for female physiology. Other studies have investigated hormonal treatments for women, such as fezolinetant for menopausal vasomotor symptoms 2, and contraception selection and effectiveness 3, but these are not relevant to the use of Kyzatrex in women.

In clinical practice, it is essential to prioritize the safety and well-being of patients, and using Kyzatrex in women would not be in line with this principle due to the potential for serious side effects. Therefore, Kyzatrex should not be used in women, and alternative treatments should be considered based on individual patient needs and medical history.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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