Overview

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:

Participant gender:

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

Details

Lead Sponsor:

San Diego Sexual Medicine

Treatments:

Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate