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

Launched by SAN DIEGO SEXUAL MEDICINE · Oct 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Kyzatrex®, which contains testosterone, to see if it can help menopausal women with a condition called hypoactive sexual desire disorder (HSDD). HSDD is when a woman has little or no interest in sexual activity, which can be distressing. In this study, women aged 30 and older who are menopausal and have low testosterone levels may be eligible to participate. Some key criteria include being in good health with a body mass index (BMI) of 34 or lower and having no significant history of diseases that could affect the study.

Participants in the trial will take a daily capsule of Kyzatrex® for three months. They will visit the research center in San Diego for check-ups, where their blood will be tested several times to monitor safety and how the body processes the medication. They will also have their vital signs measured and be asked about any side effects they might experience. This study is not yet recruiting participants, but it aims to help improve understanding and treatment options for women facing challenges with sexual desire during menopause.

Gender

FEMALE

Eligibility criteria

• 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.