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NCT06082817
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Phase 2 trial testing Oral Testosterone Undecanoate in Hypoactive Sexual Desire Disorder in 30 participants. Not yet recruiting.
31 December 2025
Quick facts
| Lead sponsor | San Diego Sexual Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Oral Testosterone Undecanoate — full drug profile →
Conditions studied
- Hypoactive Sexual Desire Disorder — all drugs for Hypoactive Sexual Desire Disorder →
Sponsor
San Diego Sexual Medicine
Who can join
Adults 21 to 75, female only, with Hypoactive Sexual Desire Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06082817
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other San Diego Sexual Medicine trials
Trials by the same sponsor.
- NCT06600893 — Sham-Controlled Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Penile LiSWT · NA · completed
- NCT03568604 — Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia · Phase 4 · completed
- NCT02714049 — Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy · Phase 4 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06082817 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by San Diego Sexual Medicine
- Last refreshed: 13 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06082817.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing