A Phase 1 interventional study of IM Saline Placebo (0.25 ml) and IM Estradiol valerate (2.5 mg) in Healthy, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Basic science
Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal women. Preliminary data are sought to estimate statistical power for more detailed studies of this hypothesis.
The systemic availability and orderly secretion patterns of GH and sex steroids decline in healthy aging men and women. The combined changes have substantial clinical implications to aging-related physical frailty, diminished aerobic capacity, sarcopenia, osteopenia, visceral adiposity, glucose intolerance, and reduced psychosocial wellbeing. Whereas androgen is considered the main trophic (anabolic) sex steroid, recent data demonstrate that certain tissues respond principally to GH and testosterone-derived estradiol, Estrogen (E2) (e.g. bone, brain, liver and pituitary). In principle, frailty may thus be associated with dual GH and sex-steroid deficiencies. Additionally, young, but not older healthy women secrete significant amounts of progesterone for approximately 14 days during the luteal phase of every menstrual cycle. When GH levels rise nearly two fold, the investigators hypothesize that progesterone potentiates the GH response to E2. This hypothesis arises from scattered indirect studies often using synthetic progestins with partial androgen agonism, instead of progesterone per se.
Because there is no basis for estimating statistical power for this novel paradigm, 40 women, 10 each in 4 groups, will be studied. The pilot data will be used to calculate statistical power for a definitive R01-based investigation of gender-specific distinctions in estrogen-regulated pituitary-hormone secretion.
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postmenopausal as defined by: any combination of the following
Exclusion Criteria:
Day 1: IM Saline Placebo (0.25 ml) Day 10: IM Saline Placebo (0.5 ml) and Oral Placebo 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days)
Drug: IM Saline Placebo (0.25 ml) · Drug: IM Saline Placebo (0.5 ml) · Drug: Oral Placebo · Drug: Ghrelin (0.3 ug/kg)
Day 1: IM Saline Placebo (0.25 ml) Day 10: IM Saline Placebo (0.5 ml) and Oral Micronized Progesterone 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days)
Drug: IM Saline Placebo (0.25 ml) · Drug: IM Saline Placebo (0.5 ml) · Drug: Oral Micronized Progesterone · Drug: Ghrelin (0.3 ug/kg) · Drug: Oral Placebo
Day 1: IM Estradiol (2.5 mg) Day 10: IM Estradiol (5.0 mg) and Oral Placebo 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Medroxyprogesterone (5 mg - for 10 days)
Drug: IM Estradiol valerate (2.5 mg) · Drug: IM Estradiol valerate (5.0 mg) · Drug: Oral Placebo · Drug: Ghrelin (0.3 ug/kg) · Drug: Medroxyprogesterone - Acetate
Day 1: IM Estradiol (2.5 mg) Day 10: IM Estradiol (5.0 mg) and Oral Micronized Progesterone 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days)
Drug: IM Estradiol valerate (2.5 mg) · Drug: IM Estradiol valerate (5.0 mg) · Drug: Oral Micronized Progesterone · Drug: Ghrelin (0.3 ug/kg) · Drug: Oral Placebo
(in lieu of Medroxyprogesterone)
Logarithm of the ratio of the normalized growth hormone secretion rate over the first 10 hr.
Subjects will be given IM placebo/estradiol on Day 1. 10 days later they will receive IM placebo/estradiol again, then start progesterone/placebo capsules for 14 days. On Day 23, subjects will undergo a 12-h overnight (2200 - 1000h) fasting, 10-min blood sampling. The primary comparison parameter is the logarithm of the ratio of the normalized growth hormone secretion rate over the first 10 hr.
Time frame: The subject will be followed on average for a month. Growth hormone measurements will occur on Day 23 after initiation of study drug administration
Growth hormone secretion post ghrelin injection
Subjects will be given IM placebo/estradiol on Day 1. 10 days later they will receive IM placebo/estradiol again, then start progesterone/placebo capsules for 14 days. On Day 23, subjects will undergo a 12-h overnight (2200 - 1000h) fasting, 10-min blood sampling. A secondary outcome is GH secretion over the 2 hr after bolus ghrelin injection, a potent growth hormone secretagogue
Time frame: The subject will be followed on average for a month. Growth hormone measurements will occur on Day 23 after initiation of study drug administration
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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