HypogonadismPhase 2NCT00104572
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
A Phase 2 study testing Androgel (Testosterone Gel), Anastrozole (Aromatase Inhibitor) and Calcium Cardone 500mg with vitamin D 400 IU in people with Hypogonadism and Diabetes, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: Men≥65 years often produce lower levels of testosterone, meaning there is less testosterone circulating to the tissues of the body. This is associated with negative effects on muscle strength, bone density, sexual function, mood, and the ability to think to the best of one's ability. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Diabetes, Sarcopenia
- What is being tested?
- Androgel (Testosterone Gel), Anastrozole (Aromatase Inhibitor) and Calcium Cardone 500mg with vitamin D 400 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men age 65 years or older
- Serum testosterone level less than or equal to 350 ng/dl
- Subject is able to complete an informed consent
Who cannot join
- History of Stroke
- History of Dementia
- History of Diabetes
- Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading renders subject ineligible
- Chronic medical condition, i.e. congestive heart failure
- Arthritis, severe enough to prevent completion of the strength testing, history of joint replacement of knees or hip.
Show all 26Show fewer
- Inability to walk 50 meters
- Known disease of the bone and/or taking medications to treat osteoporosis, i.e.
- Fosamax, Evista, Miacalcin
- History of Gastric surgery
- History of prostate cancer or any other cancers, including blood dyscrasias
- History of severe benign prostatic hyperplasia (causing urinary problems)
- History of heart attack or open-heart surgery within the past 6 months
- Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
- If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the duration of the study
- Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs of growth hormone
- Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens
- Use of Dilantin or Phenobarbital
- Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
- Currently smokes any tobacco product
- Having started a new medication during the past three months which may interfere with the outcome measures of the study
- Polycythemia
- Prostate specific antigen > 4.0 ng/dl
- Hematocrit < 36
- Liver function tests greater than 2 times upper normal limits or abnormal electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
- Mini Mental Status Exam score less than or equal to 24
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
Official title: The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men
Background: Men≥65 years often produce lower levels of testosterone, meaning there is less testosterone circulating to the tissues of the body. This is associated with negative effects on muscle strength, bone density, sexual function, mood, and the ability to think to the best of one's ability. Testosterone replacement therapy often involves injections, patches, or gels that help to raise circulating testosterone levels, but these therapies often have side effects because they lead to imbalance of other hormones. Researchers have been studying the effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously increasing testosterone levels, as a treatment for the negative effects of decreased circulating testosterone levels that occur naturally with aging. Objectives: To evaluate whether anastrozole is as effective as testosterone gel in improving bone and muscle strength, hormone levels, and brain function in men over 65 years of age. Eligibility: Healthy men at least 65 years of age who have low levels of testosterone. Design: The study involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months, 6 months, and 12 months. All participants will receive calcium and vitamin D supplements to take daily, and will be randomized to one of three groups:Testosterone gel and placebo tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine tests; growth hormone, muscle strength, bone density, and balance evaluation; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six months: Blood and urine tests; muscle strength, bone density, and balance evaluation; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms.
Read the detailed description
Approximately 20% of men over the age of 70 have low testosterone levels. In some studies, testosterone replacement has resulted in improvement in bone mass, muscle strength, quality of life and memory function. In the body, testosterone is converted into estrogen. Hence, it is unclear whether these beneficial effects are due to testosterone or estrogen. Research has shown that inhibition of estrogen production in men results in an increase in testosterone levels.
In this study, patients will be assigned to one of three groups: one group will receive testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month period for testing and evaluation. Two of the 6 visits will require an overnight stay in the hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance test, bone and muscle tests, evaluation of memory function, etc. For the safety of the prostate, we will perform a prostate ultrasound at the start and end of the study and we will monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam throughout the study.
- Conditions
- Hypogonadism, Diabetes, Sarcopenia, Osteoporosis, Depression
- Being tested
- Androgel (Testosterone Gel), Anastrozole (Aromatase Inhibitor), Placebo tablet, Placebo gel, Calcium Cardone 500mg with vitamin D 400 IU
- Keywords
- Estrogen, Glucose Tolerance, Bone Density, Quality-of-Life, Sarcopenia
- Medical subject headings
- Hypogonadism, Diabetes Mellitus, Sarcopenia, Osteoporosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgel (Testosterone Gel)Drug
1 mg tablet for 12 months
Anastrozole (Aromatase Inhibitor)Drug
Placebo tabletDrug
Daily for 12 months
Placebo gelDrug
Daily for 12 months
Calcium Cardone 500mg with vitamin D 400 IUDietary supplement
1 tablet three times a day
| Study group | Role | What they receive |
|---|---|---|
| (Androgel) testosterone gel | Experimental | 17 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU' Receives: Drug: Androgel (Testosterone Gel); Drug: Placebo tablet; Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU |
| anastrozole (Aromatase inhibitor) | Experimental | 14 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU' Receives: Drug: Anastrozole (Aromatase Inhibitor); Drug: Placebo gel; Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU |
| placebo | Placebo comparator | 13 participants will receive a placebo tablet and placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU' Receives: Drug: Placebo tablet; Drug: Placebo gel; Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo
Measured: 1 year
Secondary outcomes (3)
Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release
Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo
Measured: 1 year
Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism
Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more.
Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point.
Measured: 1 year
Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function
rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo.
Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2005 (estimated)
- Study startMar 2004
- Primary completionDec 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Josephine M Egan, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104572
- Sponsor's protocol ID
- 999904338
- Other IDs
- NCT00104572, 04-AG-N338
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2005
- Last updated
- 6 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jeffcoate SL, Brooks RV, Lim NY, London DR, Prunty FT, Spathis GS. Androgen production in hypogonadal men. J Endocrinol. 1967 Apr;37(4):401-11. doi: 10.1677/joe.0.0370401. No abstract available.
PubMed 4290227Wheeler MJ. The determination of bio-available testosterone. Ann Clin Biochem. 1995 Jul;32 ( Pt 4):345-57. doi: 10.1177/000456329503200401. No abstract available.
PubMed 7486793Gray A, Feldman HA, McKinlay JB, Longcope C. Age, disease, and changing sex hormone levels in middle-aged men: results of the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 1991 Nov;73(5):1016-25. doi: 10.1210/jcem-73-5-1016.
PubMed 1719016Dias JP, Melvin D, Shardell M, Ferrucci L, Chia CW, Gharib M, Egan JM, Basaria S. Effects of Transdermal Testosterone Gel or an Aromatase Inhibitor on Prostate Volume in Older Men. J Clin Endocrinol Metab. 2016 Apr;101(4):1865-71. doi: 10.1210/jc.2016-1111. Epub 2016 Mar 7.
PubMed 26950683
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men
- ClinicalTrials.gov ID
- NCT00104572
- Acronym / sponsor ID
- 999904338
- Conditions
- Hypogonadism, Diabetes, Sarcopenia, Osteoporosis, Depression
- Keywords
- Estrogen, Glucose Tolerance, Bone Density, Quality-of-Life, Sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2004
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Mar 2005 (estimated)
- Results
- Posted 9 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Men≥65 years often produce lower levels of testosterone, meaning there is less testosterone circulating to the tissues of the body. This is associated with negative effects on muscle strength, bone density, sexual function, mood, and the ability to think to the best of one's ability. Testosterone replacement therapy often involves injections, patches, or gels that help to raise circulating testosterone levels, but these therapies often have side effects because they lead to imbalance of other hormones. Researchers have been studying the effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously increasing testosterone levels, as a treatment for the negative effects of decreased circulating testosterone levels that occur naturally with aging. Objectives: To evaluate whether anastrozole is as effective as testosterone gel in improving bone and muscle strength, hormone levels, and brain function in men over 65 years of age. Eligibility: Healthy men at least 65 years of age who have low levels of testosterone. Design: The study involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months, 6 months, and 12 months. All participants will receive calcium and vitamin D supplements to take daily, and will be randomized to one of three groups:Testosterone gel and placebo tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine tests; growth hormone, muscle strength, bone density, and balance evaluation; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six months: Blood and urine tests; muscle strength, bone density, and balance evaluation; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms.
Detailed description
Approximately 20% of men over the age of 70 have low testosterone levels. In some studies, testosterone replacement has resulted in improvement in bone mass, muscle strength, quality of life and memory function. In the body, testosterone is converted into estrogen. Hence, it is unclear whether these beneficial effects are due to testosterone or estrogen. Research has shown that inhibition of estrogen production in men results in an increase in testosterone levels.
In this study, patients will be assigned to one of three groups: one group will receive testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month period for testing and evaluation. Two of the 6 visits will require an overnight stay in the hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance test, bone and muscle tests, evaluation of memory function, etc. For the safety of the prostate, we will perform a prostate ultrasound at the start and end of the study and we will monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (Androgel) testosterone gel | Experimental | Drug: Androgel (Testosterone Gel), Drug: Placebo tablet, Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU17 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU' |
| anastrozole (Aromatase inhibitor) | Experimental | Drug: Anastrozole (Aromatase Inhibitor), Drug: Placebo gel, Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU14 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU' |
| placebo | Placebo comparator | Drug: Placebo tablet, Drug: Placebo gel, Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU13 participants will receive a placebo tablet and placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU' |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (26 listed)
- History of Stroke
- History of Dementia
- History of Diabetes
- Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading renders subject ineligible
- Chronic medical condition, i.e. congestive heart failure
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 |
|---|---|---|
| Androgel (Testosterone Gel)1 mg tablet for 12 months | Drug | (Androgel) testosterone gel |
| Anastrozole (Aromatase Inhibitor) | Drug | anastrozole (Aromatase inhibitor) |
| Placebo tabletDaily for 12 months | Drug | (Androgel) testosterone gel, placebo |
| Placebo gelDaily for 12 months | Drug | anastrozole (Aromatase inhibitor), placebo |
| Calcium Cardone 500mg with vitamin D 400 IU1 tablet three times a day | Dietary supplement | (Androgel) testosterone gel, anastrozole (Aromatase inhibitor), placebo |
Primary outcome
Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
Time frame: 1 year
bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo
3 secondary outcomes
Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release
Time frame: 1 year
Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism
Time frame: 1 year
Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4290227Jeffcoate SL, Brooks RV, Lim NY, London DR, Prunty FT, Spathis GS. Androgen production in hypogonadal men. J Endocrinol. 1967 Apr;37(4):401-11. doi: 10.1677/joe.0.0370401. No abstract available.
- Background: PubMed 7486793Wheeler MJ. The determination of bio-available testosterone. Ann Clin Biochem. 1995 Jul;32 ( Pt 4):345-57. doi: 10.1177/000456329503200401. No abstract available.
- Background: PubMed 1719016Gray A, Feldman HA, McKinlay JB, Longcope C. Age, disease, and changing sex hormone levels in middle-aged men: results of the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 1991 Nov;73(5):1016-25. doi: 10.1210/jcem-73-5-1016.
- Derived from this study: PubMed 26950683Dias JP, Melvin D, Shardell M, Ferrucci L, Chia CW, Gharib M, Egan JM, Basaria S. Effects of Transdermal Testosterone Gel or an Aromatase Inhibitor on Prostate Volume in Older Men. J Clin Endocrinol Metab. 2016 Apr;101(4):1865-71. doi: 10.1210/jc.2016-1111. Epub 2016 Mar 7.
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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.
Josephine M Egan, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgel (Testosterone Gel), Anastrozole (Aromatase Inhibitor) and Calcium Cardone 500mg with vitamin D 400 IU in people with Hypogonadism and Diabetes, run by National Institute on Aging (NIA) 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 26 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 6 Nov 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104572, which also lists 4 linked publications.
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 6 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.