Hypogonadism, Male Clinical Trial
Official title:
A 6 Month, Open Label, Ambulatory Blood Pressure Monitoring (ABPM) Extension Study
The purpose of this six-month treatment extension study is - to assess feasibility of a lower starting dose of SOV2012-F1 (daily dose of 400 mg [200 mg with breakfast meal and 200mg with dinner meal]) to titrate individual doses in order to further enhance drug administration. - To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).
This is the six-month treatment extension of Study MRS-TU-2019, which like Study MRS-TU-2019 (NCT03198728), is an open-label study. The MRS-TU-2019 ABPM Extension Study (MRS-TU-2019EXT; NCT04467697), will extend the participation for up to 170 MRS-TU-2019 subjects who chose to enroll into the MRS-TU-2019EXT, for a target of 135 evaluable subjects reaching the 4-month ABPM assessment ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04326673 -
Salivary Testosterone in Men: Diurnal Variation and Post-Prandial Responses
|
||
| Completed |
NCT03203681 -
Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters
|
Phase 4 | |
| Completed |
NCT01904734 -
Clomid in Men With Low Testosterone With and Without Prior Treatment
|
Phase 2 | |
| Completed |
NCT00400335 -
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
|
Phase 1 | |
| Completed |
NCT00398580 -
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
|
Phase 2 | |
| Recruiting |
NCT05611307 -
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
|
||
| Completed |
NCT03282682 -
Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male
|
N/A | |
| Terminated |
NCT03335254 -
A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males
|
Phase 1/Phase 2 | |
| Terminated |
NCT05205837 -
A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial
|
Phase 4 | |
| Completed |
NCT03747003 -
Gonadal Function in Young to Middle Aged HIV-infected Men
|
||
| Withdrawn |
NCT03176537 -
Periodontal Profile of Hypogonadic Men
|
Phase 4 | |
| Recruiting |
NCT04049331 -
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
|
Phase 2 | |
| Completed |
NCT03541395 -
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
|
N/A | |
| Recruiting |
NCT05249634 -
Testosterone Treatment in Men With Chronic Kidney Disease
|
Phase 2 | |
| Not yet recruiting |
NCT05773183 -
Exploring the Relationship Between Androgen Metabolism, Metabolic Disease and Skeletal Muscle Energy Balance in Men
|
||
| Withdrawn |
NCT04717362 -
The Effects of Natesto For Treatment Of Hypogonadism
|
Early Phase 1 | |
| Completed |
NCT05806723 -
Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men
|
Phase 4 | |
| Completed |
NCT04456296 -
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
|
Phase 4 | |
| Not yet recruiting |
NCT06312761 -
Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05381831 -
Natesto Spermatogenesis Reboot
|
Phase 4 |