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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Eligible subjects will receive 50 mg capsules of Kyzatrax® to be taken orally daily over a 3-month period. Multiple blood samples will be taken at baseline and on days 7, 28 and 56 to assess safety and pharmacokinetics of the testosterone. After the informed consent is signed and for up to 84 days after baseline, subjects will have serial blood samples collected in addition to other routine study procedures (e.g. vital signs measured, adverse events assessed, validated outcome scales completed).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: San Diego Sexual Medicine
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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 21 years or greater;

4. 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.

5. Participant is in a monogamous relationship ≥ 6 months;

6. Participant has a body mass index (BMI) ≤ 35 kg/m2;

7. Participant has a history of any of the clinical symptoms of low testosterone for at least 6 months prior to the screening visit;

8. At screening, subject has a calculated free testosterone concentration < 0.6 ng/dL;

9. Participant agrees to comply with the study procedures and visits.

Exclusion Criteria:

1. Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, and 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 medication 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 any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;

7. Participant requires major surgery within 4 weeks before signing consent or at any time during the study;

8. 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;

9. Participant has a history of substance abuse within 12 months prior to signing consent;

10. Participant has received an investigational drug within 30 days prior to signing consent;

11. 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.