An Open-Label Study of 50 mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women With Low Testosterone and HSDD

Inclusion Criteria: Participant provides written informed consent and HIPAA authorization before any study procedures are conducted; Participant is female; Participant is aged 21 years or greater; Participant is menopausal either naturally (at least 12 months amenorrheic) or after a bilateral salpingo-oophorectomy prior to natural menopause. Subjects with hysterectomy only must meet the following menopause criteria: ≤54 years must be experiencing hot flushes or receiving estrogen therapy for hot flushes (if these subjects are asymptomatic they require a serum FSH > 30 mIU/mL); > 54 years is considered postmenopausal. Participant is in a monogamous relationship ≥ 6 months; Participant has a body mass index (BMI) ≤ 35 kg/m2; Participant has a history of any of the clinical symptoms of low testosterone for at least 6 months prior to the screening visit; At screening, subject has a calculated free testosterone concentration < 0.6 ng/dL; Participant agrees to comply with the study procedures and visits. Exclusion Criteria: Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, and titanium dioxide (the constituents of Kyzatrex capsule); Participant has received intramuscular testosterone injections, oral or transdermal testosterone within 4 weeks, or subcutaneous testosterone pellet within 6 months prior to the screening visit, or receives any form of testosterone other than study medication during this trial; Participant has documented or suspected breast cancer, history of heart attack or stroke; Participant has a clinically significant history of disease which could alter absorption, distribution, metabolism, or elimination, such as hepatic, renal, hematologic, gastrointestinal, respiratory, endocrine, or neurological disease; Participant has an EKG with an abnormality of clinical significance; Participant has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study; Participant requires major surgery within 4 weeks before signing consent or at any time during the study; Participant requires a treatment with any medication listed in Appendix 1 at any time between 30 days before study medication is started or any time until the end of the study; Participant has a history of substance abuse within 12 months prior to signing consent; Participant has received an investigational drug within 30 days prior to signing consent; Participant has any condition or exhibits behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.