Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
Public ClinicalTrials.gov record NCT04467697. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 6 Month, Open Label, Ambulatory Blood Pressure Monitoring (ABPM) Extension Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this six-month treatment 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 to further enhance efficacy and safety. * To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).
Study identification
- NCT ID
- NCT04467697
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 155 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 18, 2018 (Actual)
- Primary completion
- May 1, 2020 (Actual)
- Completion
- May 1, 2020 (Actual)
- Last update posted
- Jun 28, 2024
2018 – 2020
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| Coastal Clinic Research Inc | Mobile | Alabama | 36608 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Jacksonville Impotence Treatment Center | Jacksonville | Florida | 32223 | — |
| My Community Research Center | Miami | Florida | 33155 | — |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Centex Studies, Inc. | Lake Charles | Louisiana | 70601 | — |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | — |
| Palm Research Center, Inc. | Las Vegas | Nevada | 89148 | — |
| Accumed Research Associates | Garden City | New York | 11530 | — |
| Manhattan Medical Research Practice, PLLC | New York | New York | 10016 | — |
| Rapha Institute for Clinical Research | Fayetteville | North Carolina | 28314 | — |
| Urologic Consultant of SE Pennyslvania | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| University Diabetes Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| Centex Studies, Inc. | Houston | Texas | 77058 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04467697, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 28, 2024 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04467697 live on ClinicalTrials.gov.