Impact of Estradiol Addback

NCT01862835 | Completed Phase 1

• 1 other identifier: 13-000047
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.

Conditions

Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  Subjects will undergo 15-h overnight (2200 - 1300 h) fasting, 10-min blood sampling

Study Arms (4)

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.

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.

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.

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.

Drug: Degarelix

Interventions

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

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy men (ages 60 to 80 y);
• BMI 18-30 kg/m2
• Community dwelling; and voluntarily consenting

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Testosterone; Anastrozole

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johannes Veldhuis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: May 1, 2013
• Primary Completion: September 30, 2016
• Study Completion: December 30, 2018
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)