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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: Clinical Trial Phase 2 study, sponsored by San Diego Sexual Medicine.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
serum concentration of total testosterone to assess safety (adverse events) and pharmacokinetics
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 |
What is known before NCT06082817 opens enrollment
NCT06082817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Oral Testosterone Undecanoate is the first listed.
NCT06082817 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06082817's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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