HealthyPhase 1NCT02272647
Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women
A Phase 1 study testing IM Estradiol valerate (2.5 mg), IM Estradiol valerate (5.0 mg) and Oral Micronized Progesterone in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IM Estradiol valerate (2.5 mg), IM Estradiol valerate (5.0 mg) and Oral Micronized Progesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
- anemia, hemoglobin less than 12.5 g/dl
- abnormal hepatorenal function, creatinine outside normal range, ALT greater than two times normal range
- biochemical and chemistry lab results out of physician acceptable range
- history of deep-vein thrombophlebitis
- history of Congestive Heart Failure, cardiac arrhythmias, and medications used to treat cardiac arrhythmias
- known allergy to estradiol valerate, castor oil or sesame oil
- history of smoking within the last 2 years
- untreated gall bladder disease
- lack of voluntary, written informed consent
- history of carcinoma excluding localized basal cell or squamous cell, including women with known, suspected or history of breast cancer
- not clinically postmenopausal
- women with allergies to nuts will not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- IM Saline Placebo (0.25 ml), IM Estradiol valerate (2.5 mg), IM Saline Placebo (0.5 ml), IM Estradiol valerate (5.0 mg), Oral Micronized Progesterone
- Keywords
- Normal Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM Saline Placebo (0.25 ml)Drug
IM Estradiol valerate (2.5 mg)Drug
IM Saline Placebo (0.5 ml)Drug
IM Estradiol valerate (5.0 mg)Drug
Oral Micronized ProgesteroneDrug
Oral PlaceboDrug
Ghrelin (0.3 ug/kg)Drug
Medroxyprogesterone - AcetateDrug
Oral PlaceboDrug
(in lieu of Medroxyprogesterone)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: The subject will be followed on average for a month. Growth hormone measurements will occur on Day 23 after initiation of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes D. Veldhuis, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272647
- Sponsor's protocol ID
- 14-002829
- Status last verified
- Mar 2018
- First submitted
- 21 Oct 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women
- ClinicalTrials.gov ID
- NCT02272647
- Acronym / sponsor ID
- 14-002829
- Conditions
- Healthy
- Keywords
- Normal Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IM Plac - Oral Plac - Ghrelin | Experimental | 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 Placebo 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days) |
| IM Plac - Oral Prog - Ghrelin | Experimental | 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 PlaceboDay 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) |
| IM E2 - Oral Plac - Ghrelin | Experimental | 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 - AcetateDay 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) |
| IM E2 - Oral Prog - Ghrelin | Experimental | 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 PlaceboDay 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) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- women ages 50 to 80
- postmenopausal as defined by: any combination of the following
- Following laboratory results with normal range, unless PI approves out of range values.
- BMI 18 to 35
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| Oral Placebo(in lieu of Medroxyprogesterone) | Drug | IM E2 - Oral Prog - Ghrelin, IM Plac - Oral Plac - Ghrelin, IM Plac - Oral Prog - Ghrelin |
Primary outcome
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
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.
1 secondary outcome
Growth hormone secretion post ghrelin injection
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IM Estradiol valerate (2.5 mg), IM Estradiol valerate (5.0 mg) and Oral Micronized Progesterone in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.