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NCT06082817 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
A Phase 2 study, sponsored by San Diego Sexual Medicine.
- Not yet
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT06082817 is a Phase 2 study that has not yet begun recruiting, run by San Diego Sexual Medicine. The registered enrollment target is 30 participants.
The verdict
NCT06082817, a Phase 2 study, has not yet begun recruiting, sponsored by San Diego Sexual Medicine.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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 14 days after the last dose of study drug, participants 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).
Interventions
- DRUG Oral Testosterone Undecanoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06082817
The ClinicalTrials.gov registry entry for NCT06082817 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is San Diego Sexual Medicine, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oral Testosterone Undecanoate is the first listed.
NCT06082817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06082817 about?
NCT06082817 is a clinical study titled "An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD". 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...
What is the current status of trial NCT06082817?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-01-01. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT06082817?
The interventions under investigation include: Oral Testosterone Undecanoate (DRUG).
Who is sponsoring clinical trial NCT06082817?
This trial is sponsored by San Diego Sexual Medicine, which has 4 total clinical trials registered on ClinicalTrials.gov.
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