Status:
NOT_YET_RECRUITING
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Lead Sponsor:
San Diego Sexual Medicine
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
21-75 years
Phase:
PHASE2
Brief 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 pe...
Detailed Description
This study is being conducted in an unblinded fashion because the primary endpoint is pharmacokinetic information, and all subjects will receive the same active drug at the same dosage. The primary ob...
Eligibility Criteria
Inclusion
- Participant provides written informed consent and HIPAA authorization before any study procedures are conducted;
- Participant is female;
- Participant is aged 30 years or greater;
- 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.
- Participant has a body mass index (BMI) ≤ 34 kg/m2;
- Participant has a diagnosis of hypoactive sexual desire disorder;
- At screening, participant has a testosterone concentration \<30 ng/dL;
- Participant has a normal PAP smear within 6 months of first administration of study drug if participant has a cervix;
- Participant has a normal mammogram within 6 months of first administration of study drug;
- Participant agrees to comply with the study procedures and visits.
Exclusion
- Participant has a hypersensitivity to testosterone, gelatin, glycerin, sorbitol, or 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 drug 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 an abnormal PAP smear if she has a cervix;
- 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 drug 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 participant is unlikely to be compliant with study procedures and visits.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06082817
Start Date
January 1 2025
End Date
December 31 2025
Last Update
November 13 2024
Active Locations (1)
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1
San Diego Sexual Medicine
San Diego, California, United States, 92120