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Home › Conditions › Male hypogonadism

Male hypogonadism

2 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Male hypogonadism

19 trials tracked for Male hypogonadism: 14 in phase 3 or 4 and 8 with published results. The most-cited published study has 81 citations.

19Trials tracked
14Phase 3 & 4
0Recruiting
8With published results
Phase distribution
Phase 4 4 Phase 3 10 Phase 2 4 Other / NA 1
  1. Phase 3 Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism Completed · 81 cited
  2. Phase 3 Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men Completed · 28 cited
  3. Phase 3 Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). Completed · 17 cited
  4. Phase 3 Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men Completed · 14 cited
  5. Phase 3 Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men Completed · 14 cited
  6. Phase 4 A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections Completed · 8 cited
Show 13 more trials
  1. Phase 3 Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men Completed · 6 cited
  2. Phase 3 Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men Completed · 5 cited
  3. Phase 4 Subcutaneous vs. Intramuscular Testosterone Completed
  4. Phase 4 Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters Completed
  5. Phase 4 A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism Completed
  6. Phase 3 Safety and Efficacy Trial of Testosterone Undecanoate Completed
  7. Phase 3 Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) Completed
  8. Phase 3 Time to Eugonadal Range, Time to Steady State and Drying Time Completed
  9. Phase 2 Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function Completed
  10. Phase 2 Pharmacokinetic Study to Determine Time to Steady-state Completed
  11. Phase 2 5-Alpha Reductase and Anabolic Effects of Testosterone Completed
  12. Phase 2 Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation Completed
  13. N/A Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male Completed

Showing the 19 most-cited and recently-updated of 19 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Male hypogonadism: what the trials found

Treatment with various testosterone formulations has demonstrated efficacy in improving hormonal profiles and clinical markers. Natesto was associated with a change of 652 in testosterone levels, 21.6 in estradiol levels, and 3.0 to 2.6 in gonadotropin levels over 27 weeks 3. Oral testosterone undecanoate showed high success rates in achieving average serum testosterone concentrations between 300 and 1000 ng/dL (83.6% and 79.2%) 9.

Specific testosterone interventions demonstrated significant reach in clinical targets. LPCN 1021 treatment resulted in 80% of subjects achieving average total testosterone concentrations in the normal range 7 and 69% of subjects reaching the same target in another study 12. Additionally, oral SOV2012-F1 was shown to maintain average plasma total testosterone within the normal range in 166% of male hypogonadal subjects 11.

Clinical outcomes for specific formulations include a change of 4.8 in IIEF-6 scores with Testosterone Cypionate 1. Regarding metabolic and physical markers, LPCN 1021 showed significant reductions in MRI-PDFF (ranging from -13.5% to -38.5% depending on baseline levels) 6.

Safety and secondary outcomes for specific treatments include the observation that 1.4%, 1.5%, and 2.2% of patients taking Aveed required new antihypertensive medications, while 0% required dose increases 2. SOV2012-F1 was associated with consistent changes in ambulatory systolic blood pressure (approximately 128.9 to 130.7) and diastolic blood pressure (approximately 76.2 to 76.9) over 120 to 180 days 10.

Recent results — preliminary, needs further review

  • Testosterone undecanoate showed a statistically significant increase in mean T Cavg25 following meals containing various amounts of dietary fat compared to a normal fat diet (p=0.0025) 16.
  • Testosterone Enanthate was associated with improvements in 1-RM strength testing (p=<0.001), grip strength (p=0.015), and lumbar spine L2-L4 bone mineral density (p=<0.001) 18.

For the clinician treating this condition

  • Multiple testosterone delivery methods, including oral undecanoate and LPCN 1021, effectively maintain serum testosterone within normal ranges.
  • Testosterone Cypionate is associated with measurable improvements in IIEF-6 scores.
  • LPCN 1021 demonstrates significant efficacy in reducing MRI-PDFF levels.

AI synthesis of 11 cited trials, updated Jun 25, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
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