Normal Healthy VolunteersPhase 1NCT01862835
Impact of Estradiol Addback
A Phase 1 study testing Degarelix, Testosterone and Anastrozole in people with Normal Healthy Volunteers, run by Mayo Clinic at 1 site in United States.
Trial summary
Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Volunteers
- What is being tested?
- Degarelix, Testosterone and Anastrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 30 Dec 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 60 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 healthy men (ages 60 to 80 y);
- BMI 18-30 kg/m2
- Community dwelling; and voluntarily consenting
Who cannot join
- Recent use of psychotropic or neuroactive drugs (within five biological half-live);
- Obesity (outside weight range above);
- Laboratory test results not deemed physician acceptable, cholesterol >250, triglycerides > 300, BUN >30 or creatinine > 1.5 mg/dL, liver functions tests twice upper limit of normal, electrolyte abnormality, anemia; hemoglobin <12.0 gm/dL
- Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
- Acute or chronic organ-system disease;
- Endocrinopathy, other than primary thyroidal failure receiving replacement; untreated osteoporosis
Show all 18Show fewer
- Nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
- Acute weight change (loss or gain of > 2 kg in 6 weeks);
- Allergy to peanut oil (used in some injectable Te preparations)
- Unwillingness to provide written informed consent.
- PSA > 4.0 ng/mL
- History or suspicion of prostatic disease (elevated PSA, indeterminate nodule or mass, obstructive uropathy.
- History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence.
- History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis.
- History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias
- Gynecomastia > 2 cm, untreated
- Untreated gallbladder disease
- History of smoking greater than one ppd.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Impact of Estradiol Addback on Somatostatin Rebound in Older Men
Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.
Read the detailed description
Systemic concentrations of Te, E2, GH, Insulin-like Growth Factor-I and IGFBP-3 decline in healthy aging men. Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since Te stimulates GH and IGF-I production in older men, hypogonadal males of all ages, and patients undergoing (genotypic female-to-male) gender reassignment. Tamoxifen blocks this effect of Te, suggesting involvement of E2 in GH's stimulation in men. E2 per se stimulates GH secretion in women. Because Te is converted to E2 by aromatization in the body, we postulate that E2 is the active moiety in men also. Moreover, we hypothesize that the decline of E2 in older men contributes to the fall in GH output. This has never been tested. From a clinical vantage, understanding the mechanistic basis of Te's drive of the somatotropic axis is especially relevant in boys with pubertal failure, adults with primary hypogonadism and men with aging-related hypoandrogenemia. In relation to aging in the male, testosterone and E2 bioavailabilities fall by 35-50% in the eighth compared with third decade of life. From a medical perspective, aging is accompanied by progressive osteopenia, sarcopenia and intra-abdominal obesity. These adverse outcomes are remediable by short-term replacement with Te and/or recombinant GH, thus linking GH/Te/E2 availability with key body-compositional features.
- Conditions
- Normal Healthy Volunteers
- Being tested
- Degarelix, Testosterone, Anastrozole, Estrogen patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
TestosteroneDrug
AnastrozoleDrug
Estrogen patchDrug
| Study group | Role | What they receive |
|---|---|---|
| Degarelix/Te/placebo/ placebo | Experimental | Degarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; Te enanthate 100 mg i.m. given on day 1, 8 and 15; Oral placebo once daily x 22 days; and no patch beginning on day 1 and changed every 3 days through day 22. Receives: Drug: Degarelix; Drug: Testosterone |
| degarelix/Te/anastrozole/ placebo | Experimental | degarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; Te enanthate 100 mg i.m. given on day 1, 8 and 15; Oral anastrozole 2.0 mg once daily x 22 days; and no patch beginning on day 1 and changed every 3 days through day 22. Receives: Drug: Degarelix; Drug: Testosterone; Drug: Anastrozole |
| degarelix/Te/ anastrozole/E2 patch | Experimental | degarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; Te enanthate 100 mg i.m. given on day 1, 8 and 15; Oral anastrozole 2.0 mg once daily x 22 days; and an E2 patch calibrated to deliver 0.05 mg/day E2 beginning on day 1 and changed every 3 days through day 22. Receives: Drug: Degarelix; Drug: Testosterone; Drug: Anastrozole; Drug: Estrogen patch |
| degarelix/ placebo/placebo/no patch | Experimental | degarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; placebo i.m. given on day 1, 8 and 15; Oral placebo once daily x 22 days; and no patch beginning on day 1 and changed every 3 days through day 22. Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
BioStatistical Analysis
The primary analytical outcome is the summed mass of GH secreted in pulses over the 15 h of overnight blood sampling. The outcome measure is relevant, since sex-steroid hormones and regulatory peptides uniquely control GH secretory-burst mass.
Measured: Subjects will undergo 15-h overnight (2200 - 1300 h) fasting, 10-min blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completion30 Sep 2016
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy VolunteersStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes D. Veldhuis, Mayo Clinic
- Investigators
- Johannes Veldhuis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862835
- Sponsor's protocol ID
- 13-000047
- Status last verified
- Jun 2019
- First submitted
- 22 May 2013
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Estradiol Addback on Somatostatin Rebound in Older Men
- ClinicalTrials.gov ID
- NCT01862835
- Acronym / sponsor ID
- 13-000047
- Conditions
- Normal Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 27 May 2013 (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.
Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.
Detailed description
Systemic concentrations of Te, E2, GH, Insulin-like Growth Factor-I and IGFBP-3 decline in healthy aging men. Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since Te stimulates GH and IGF-I production in older men, hypogonadal males of all ages, and patients undergoing (genotypic female-to-male) gender reassignment. Tamoxifen blocks this effect of Te, suggesting involvement of E2 in GH's stimulation in men. E2 per se stimulates GH secretion in women. Because Te is converted to E2 by aromatization in the body, we postulate that E2 is the active moiety in men also. Moreover, we hypothesize that the decline of E2 in older men contributes to the fall in GH output. This has never been tested. From a clinical vantage, understanding the mechanistic basis of Te's drive of the somatotropic axis is especially relevant in boys with pubertal failure, adults with primary hypogonadism and men with aging-related hypoandrogenemia. In relation to aging in the male, testosterone and E2 bioavailabilities fall by 35-50% in the eighth compared with third decade of life. From a medical perspective, aging is accompanied by progressive osteopenia, sarcopenia and intra-abdominal obesity. These adverse outcomes are remediable by short-term replacement with Te and/or recombinant GH, thus linking GH/Te/E2 availability with key body-compositional features.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Degarelix/Te/placebo/ placebo | Experimental | Drug: Degarelix, Drug: TestosteroneDegarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; Te enanthate 100 mg i.m. given on day 1, 8 and 15; Oral placebo once daily x 22 days; and no patch beginning on day 1 and changed every 3 days through day 22. |
| degarelix/Te/anastrozole/ placebo | Experimental | Drug: Degarelix, Drug: Testosterone, Drug: Anastrozoledegarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; Te enanthate 100 mg i.m. given on day 1, 8 and 15; Oral anastrozole 2.0 mg once daily x 22 days; and no patch beginning on day 1 and changed every 3 days through day 22. |
| degarelix/Te/ anastrozole/E2 patch | Experimental | Drug: Degarelix, Drug: Testosterone, Drug: Anastrozole, Drug: Estrogen patchdegarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; Te enanthate 100 mg i.m. given on day 1, 8 and 15; Oral anastrozole 2.0 mg once daily x 22 days; and an E2 patch calibrated to deliver 0.05 mg/day E2 beginning on day 1 and changed every 3 days through day 22. |
| degarelix/ placebo/placebo/no patch | Experimental | Drug: Degarelixdegarelix 80 mg (given as two s.c. injections of 60 mg) once [called day 1]; placebo i.m. given on day 1, 8 and 15; Oral placebo once daily x 22 days; and no patch beginning on day 1 and changed every 3 days through day 22. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 healthy men (ages 60 to 80 y);
- BMI 18-30 kg/m2
- Community dwelling; and voluntarily consenting
Key exclusion criteria (18 listed)
- Recent use of psychotropic or neuroactive drugs (within five biological half-live);
- Obesity (outside weight range above);
- Laboratory test results not deemed physician acceptable, cholesterol >250, triglycerides > 300, BUN >30 or creatinine > 1.5 mg/dL, liver functions tests twice upper limit of normal, electrolyte abnormality, anemia; hemoglobin <12.0 gm/dL
- Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
- Acute or chronic organ-system disease;
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 |
|---|---|---|
| Degarelix | Drug | Degarelix/Te/placebo/ placebo, degarelix/ placebo/placebo/no patch, degarelix/Te/ anastrozole/E2 patch, degarelix/Te/anastrozole/ placebo |
| Testosterone | Drug | Degarelix/Te/placebo/ placebo, degarelix/Te/ anastrozole/E2 patch, degarelix/Te/anastrozole/ placebo |
| Anastrozole | Drug | degarelix/Te/ anastrozole/E2 patch, degarelix/Te/anastrozole/ placebo |
| Estrogen patch | Drug | degarelix/Te/ anastrozole/E2 patch |
Primary outcome
BioStatistical Analysis
Time frame: Subjects will undergo 15-h overnight (2200 - 1300 h) fasting, 10-min blood sampling
The primary analytical outcome is the summed mass of GH secreted in pulses over the 15 h of overnight blood sampling. The outcome measure is relevant, since sex-steroid hormones and regulatory peptides uniquely control GH secretory-burst mass.
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 7 Jun 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Johannes Veldhuis, MD principal investigator
Mayo Clinic
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 Degarelix, Testosterone and Anastrozole in people with Normal Healthy Volunteers, 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 3 inclusion and 18 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 7 Jun 2019. 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?
BioStatistical Analysis (time frame: Subjects will undergo 15-h overnight (2200 - 1300 h) fasting, 10-min blood sampling). 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 7 Jun 2019.