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NCT02271282 · ClinicalTrials.gov registry record · Phase 1
Estradiol-Receptor Blockade in Older Men and Women
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02271282: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02271282 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02271282, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in prostatic cancer
Primary Outcome
Subjects will be given toremifene/placebo on Day 1 to take for 10 days. For one night between Days 8-12, from date of randomization, subjects will undergo a 12-h overnight (2200-1000h) fasting, every 10-min blood sampling. The primary analytical outcome is the summed mass of growth hormone (ie. mean/min/max) secreted in pulses over the first 10h of overnight blood samples. Pulsatile growth hormone is relevant, since sex-steroid hormones and regulatory peptides uniquely control growth hormone sec
Interventions
- DRUG Placebo
- DRUG Toremifene
- DRUG GHRH/Ghrelin combined Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT02271282 record still lists
NCT02271282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02271282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02271282 about?
NCT02271282 is a clinical study titled "Estradiol-Receptor Blockade in Older Men and Women". Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (...
What is the current status of trial NCT02271282?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2014-12. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02271282?
The interventions under investigation include: Placebo (DRUG), Toremifene (DRUG), GHRH/Ghrelin combined Injection (DRUG).
Who is sponsoring clinical trial NCT02271282?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02271282's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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