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NCT04274894 · ClinicalTrials.gov registry record · Phase 4
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
A Phase 4 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 246
- Enrollment target
NCT04274894 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 246 participants.
The verdict
NCT04274894, a Phase 4 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 246 participants
- Enrollment target
Study Summary
Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone levels along with signs and symptoms of androgen deficiency, including delayed development or regression of sexual characteristics, impaired sexual function and sense of well-being, depressed mood, decreased muscle strength associated with loss of muscle mass and reduced bone mineral density. AndroGel 1.62% has demonstrated its ability to increase total testosterone levels in the blood by absorption of testosterone through the skin when applied topically. This study evaluated the effect of AndroGel 1.62% on systolic blood pressure using ambulatory blood pressure monitoring in hypogonadal men who used testosterone replacement therapy. AndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low or no testosterone. This was an open-label study which means that both the study doctor and study participants knew what drug and what dose is being used. All participants in this study were in the same group, called a treatment arm. Adult male participants with hypogonadism were enrolled and received AndroGel 1.62%. This was a multi-center study with 190 participants enrolled (initially planned) in approximately 45 sites in the United States to yield 171 subjects in the per protocol (PP) population. A blinded sample size re-estimation (BSSR) was performed when around 70% of the planned subjects in the PP population had completed the end of treatment visit. Sample size was increased at BSSR and 246 participants were actually enrolled. Participants received daily topical gel doses of AndroGel 1.62% for approximately 16 weeks. There may have been a higher burden for participants in this study compared to standard of care. Participants attended 8 study visits during the course of the study at a hospital or clinic and received 2 study phone calls. The effect of the treatment was checked by medical assessments, blood tests (including pharmacokinetic sampling),
Interventions
- DRUG AndroGel 1.62%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2020-05-12 |
| Est. Completion | 2022-01-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04274894
The ClinicalTrials.gov registry entry for NCT04274894 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AndroGel 1.62% is the first listed.
NCT04274894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04274894 about?
NCT04274894 is a clinical study titled "A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism". Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone levels along with signs and symptoms of androgen deficiency, including delayed development or regression of sexual characteristics, impaired sexual function and sense of well-being, depressed mood, decreased musc...
What is the current status of trial NCT04274894?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 246 participants. The study started on 2020-05-12. Estimated completion is 2022-01-07.
What interventions are being tested in trial NCT04274894?
The interventions under investigation include: AndroGel 1.62% (DRUG).
Who is sponsoring clinical trial NCT04274894?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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