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NCT02959853 · ClinicalTrials.gov registry record · Phase 4
Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)
A Phase 4 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT02959853 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 23 participants.
The verdict
NCT02959853, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
After the age of 40, there is a gradual decline in the production of testosterone. Among obese men, the decline in testosterone levels is exacerbated by the suppression of the hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in turn exert a negative feedback on the hypothalamus and pituitary, leading to the inhibition of production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH), and as a consequence, of testosterone by the testis resulting in hypogonadotropic hypogonadism (HH). Though bone loss is a well recognized side effect of AI in certain populations, such as women with breast cancer, HH obese men present high levels of circulating estrogens that could potentially prevent them from bone loss, estradiol being the main regulator of the male skeleton. This study is designed to determine if aromatase inhibitors in combination with weight loss, compared to weight loss alone, will have a positive effect on muscle strength, symptoms of hypogonadism, and body composition without negatively impacting bone mineral density and bone quality. Results from this study will help determine if certain groups of obese patients would benefit from therapy with aromatase inhibitors.
Interventions
- DRUG Anastrazole
- BEHAVIORAL weight loss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-12-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02959853
The ClinicalTrials.gov registry entry for NCT02959853 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anastrazole is the first listed.
NCT02959853 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02959853 about?
NCT02959853 is a clinical study titled "Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)". After the age of 40, there is a gradual decline in the production of testosterone. Among obese men, the decline in testosterone levels is exacerbated by the suppression of the hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase enzyme in the adipose tissue enha...
What is the current status of trial NCT02959853?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2016-06. Estimated completion is 2018-12-20.
What interventions are being tested in trial NCT02959853?
The interventions under investigation include: Anastrazole (DRUG), weight loss (BEHAVIORAL).
Who is sponsoring clinical trial NCT02959853?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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