Clinical Research Directory

Inclusion Criteria: 1. Participant provides written informed consent and HIPAA authorization before any study procedures are conducted; 2. Participant is female; 3. Participant is aged 30 years or greater; 4. Participant is menopausal either spontaneously (at least 12 months amenorrheic or 6 months amenorrheic and FSH \>40 IU/ml) or 6 weeks after bilateral salpingo-oophorectomy with or without hysterectomy. 5. Participant has a body mass index (BMI) ≤ 34 kg/m2; 6. Participant has a diagnosis of hypoactive sexual desire disorder; 7. At screening, participant has a testosterone concentration \<30 ng/dL; 8. Participant has a normal PAP smear within 6 months of first administration of study drug if participant has a cervix; 9. Participant has a normal mammogram within 6 months of first administration of study drug; 10. Participant agrees to comply with the study procedures and visits. Exclusion Criteria: 1. Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, or titanium dioxide (the constituents of Kyzatrex capsule); 2. 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 drug during this trial; 3. Participant has documented or suspected breast cancer, history of heart attack or stroke; 4. 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; 5. Participant has an EKG with an abnormality of clinical significance; 6. Participant has an abnormal PAP smear if she has a cervix; 7. Participant has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study; 8. Participant requires major surgery within 4 weeks before signing consent or at any time during the study; 9. Participant requires a treatment with any medication listed in Appendix 1 at any time between 30 days before study drug is started or any time until the end of the study; 10. Participant has a history of substance abuse within 12 months prior to signing consent; 11. Participant has received an investigational drug within 30 days prior to signing consent; 12. Participant has any condition or exhibits behavior that indicates to the Principal Investigator that the participant is unlikely to be compliant with study procedures and visits.