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NCT03490513 · ClinicalTrials.gov registry record · Phase 4
Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism
A Phase 4 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT03490513 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 121 participants.
The verdict
NCT03490513, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study Summary
The investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased conversion of androgens into estrogens in obese men results in a negative feedback of high estradiol levels on hypothalamus and pituitary, inhibiting the production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone administration could increase estradiol production, further promoting the inhibitory feedback to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification has been shown to reduce estradiol and increase testosterone levels, the effect is at best modest and weight regain results in recurrence of hypogonadism. The use of aromatase inhibitors, in combination with weight loss, could be an effective alternative strategy due to its action at the pathophysiology of the disease. Intervention Subjects (body mass index of ≥35, testosterone \<300 ng/dl) will be randomized to the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be self-administered with or without food, at around the same time every day (active group); placebo 1 tablet/day with or without food to take at around the same time every day (control group). The study duration will be 12 months. Both groups will undergo lifestyle intervention consisting of diet and supervised exercise program. Target weight loss will be at least 10% of baseline body weight during the intervention. Subjects will attend weekly group behavior modification sessions which will last \~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months. Subjects will attend supervised research center-based exercise sessions during the first 6 months followed
Interventions
- DRUG Placebo
- DRUG anastrozole (1 mg/day)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2018-04-15 |
| Est. Completion | 2025-05-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03490513
The ClinicalTrials.gov registry entry for NCT03490513 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 121 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 Placebo is the first listed.
NCT03490513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03490513 about?
NCT03490513 is a clinical study titled "Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism". The investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased conversion of androgens into ...
What is the current status of trial NCT03490513?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2018-04-15. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT03490513?
The interventions under investigation include: Placebo (DRUG), anastrozole (1 mg/day) (DRUG).
Who is sponsoring clinical trial NCT03490513?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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