Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women

NCT02272647 | Completed Phase 1 DMC

• 1 other identifier: 14-002829
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  The subject will be followed on average for a month. Growth hormone measurements will occur on Day 23 after initiation of study drug administration

Secondary Outcomes (1)

• Growth hormone secretion post ghrelin injection

  The subject will be followed on average for a month. Growth hormone measurements will occur on Day 23 after initiation of study drug administration

Study Arms (4)

IM Plac - Oral Plac - Ghrelin

EXPERIMENTAL

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)

IM Plac - Oral Prog - Ghrelin

EXPERIMENTAL

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

IM E2 - Oral Plac - Ghrelin

EXPERIMENTAL

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

IM E2 - Oral Prog - Ghrelin

EXPERIMENTAL

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

Interventions

IM Saline Placebo (0.25 ml) DRUG

IM Plac - Oral Plac - Ghrelin; IM Plac - Oral Prog - Ghrelin

IM Estradiol valerate (2.5 mg) DRUG

IM E2 - Oral Plac - Ghrelin; IM E2 - Oral Prog - Ghrelin

IM Saline Placebo (0.5 ml) DRUG

IM Plac - Oral Plac - Ghrelin; IM Plac - Oral Prog - Ghrelin

IM Estradiol valerate (5.0 mg) DRUG

IM E2 - Oral Plac - Ghrelin; IM E2 - Oral Prog - Ghrelin

Oral Micronized Progesterone DRUG

IM E2 - Oral Prog - Ghrelin; IM Plac - Oral Prog - Ghrelin

Oral Placebo DRUG

IM E2 - Oral Plac - Ghrelin; IM Plac - Oral Plac - Ghrelin

Ghrelin (0.3 ug/kg) DRUG

IM E2 - Oral Plac - Ghrelin; IM E2 - Oral Prog - Ghrelin; IM Plac - Oral Plac - Ghrelin; IM Plac - Oral Prog - Ghrelin

Medroxyprogesterone - Acetate DRUG

IM E2 - Oral Plac - Ghrelin

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women ages 50 to 80
• postmenopausal as defined by: any combination of the following
• Hormonally postmenopausal for 1 year
• Lh greater than 15 IU/L, FSH greater than 30 IU/L
• Total hysterectomy with oophorectomy greater than one year
• Hysterectomy with ovaries preserved with hormone levels: Lh \> 15 IU/L, FSH \> 30 IU/L
• Following laboratory results with normal range, unless PI approves out of range values.
• BMI 18 to 35

You may not qualify if:

• structural hypothalamo-pituitary-gonadal disease
• endocrinopathy (diseases involving the following organs pituitary, thyroid, adrenals, ovaries, testes and pancreas), other than primary thyroid failure receiving replacement
• recent (within 2 weeks) estrogen, progestin, anabolic steroid or glucocorticoid use
• clinically significant ECG abnormality as determined by study team physicians
• obstructive uropathy
• history of a stroke
• history of MI or angina
• acute or chronic systemic disease
• recent transmeridian travel (traversing more than 3 time zones within 7 days of admission)
• current night shift work
• concurrent use of neuropsychiatric medications
• alcohol or drug abuse, current and within 2 years
• history of depression, psychosis, or mania
• weight gain or loss (2 kg or more in 3 weeks)
• BMI \> 35 kg/m2

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Progesterone; Ghrelin; Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Medroxyprogesterone; Hydroxyprogesterones

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

US (1)