Hypogonadism, MalePhase 2CAPNCT03933618
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
A Phase 2 study testing Anastrozole 1mg and Clomiphene Citrate 25mg in people with Hypogonadism, Male, run by Albany Medical College.
Trial summary
This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- Anastrozole 1mg and Clomiphene Citrate 25mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2015to 8 Mar 2017
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 18-70
- Baseline morning Testosterone 150-350 ng/dL x2
- leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
- Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
- Body mass index (BMI) <40
- Sexual health inventory for men (SHIM) score >7 and <21. Patients are allowed to be taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline, however we will ask them to do the SHIM survey as if they were not taking this medication.
- Men must attempt to have at least four sexual encounters over each of the eight-week periods
- Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study
Who cannot join
- Current or previous history of prostate cancer
- Previous or current androgen deprivation therapy for prostate cancer,
- Past surgical history of prostatectomy.
- History of testicular cancer.
- History of deep vein thrombosis (DVT) or blood dyscrasia
- History of breast cancer
Show all 18Show fewer
- Men with past or current treatment for erectile dysfunction including MUSE (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or men who are on phosphodiesterase inhibitors will be allowed to be in the study but must stop their use at the screening visit.
- Chronic opioid use
- Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
- History of or current use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or any growth promoters i.e. growth hormone itself or analogs of growth hormone
- History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet, estrogens
- Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
- Having started a new medication during the past three months which may interfere with the outcome measures of the study
- Polycythemia (HCT >52% )
- History of prostate specific antigen (PSA)> 4.0 ng/dl
- Hematocrit (HCT)< 36 %
- Liver function tests greater than 2 times upper normal limits or history of abnormal electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the investigator.
- Previous hypogonadal treatment within last 3 months. -
About this study
Official title: A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales
This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.
Read the detailed description
Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels. Using these medications, we can obtain therapeutic testosterone levels with either an increase or decrease in estradiol levels.
- Conditions
- Hypogonadism, Male
- Being tested
- Anastrozole 1mg, Clomiphene Citrate 25mg, Placebo - Cap
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastrozole 1mgDrug
Clomiphene Citrate 25mgDrug
Placebo - CapDrug
| Study group | Role | What they receive |
|---|---|---|
| anastrazole-clomiphene-placebo | Other | anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Receives: Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap |
| anastrazole-placebo-clomiphene | Other | anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Receives: Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap |
| clomiphene-anastrazole-placebo | Other | clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Receives: Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap |
| clomiphene-placebo-anastrazole | Other | clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Receives: Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap |
| placebo-clomiphene-anastrazole | Other | placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Receives: Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap |
| placebo-anastrazole-clomiphene | Other | placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Receives: Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF (International Index of Erectile Function) Score - Screen
15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Measured: At baseline
IIEF (International Index of Erectile Function) Score - Week 8
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Measured: Week 8
IIEF (International Index of Erectile Function) Score - Week 16
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Measured: Week 16
IIEF (International Index of Erectile Function) Score - Week 24
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Measured: Week 24
Secondary outcomes (36)
Normalized Testosterone - Screen
Normalized at >350ng/dl
Measured: Baseline
Normalized Testosterone - Week 8
Normalized at >350ng/dl
Measured: Week 8
Normalized Testosterone - Week 16
Normalized at >350ng/dl
Measured: Week 16
Normalized Testosterone - Week 24
Normalized at >350ng/dl
Measured: Week 24
ADAM (Androgen Deficiency in the Aging Male) Score - Screen
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Measured: Baseline
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Measured: Week 8
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Measured: Week 16
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
Self reported quantification of hypogonadism. 10 "yes" or "no" questions.
A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions.
Yes (1) represents a better outcome than No (1)
In Data Entry:
Yes - 1 No - 0
Measured: Week 24
EHS (Erectile Hardness Score) - Screen
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Measured: Baseline
EHS (Erectile Hardness Score) - Week 8
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Measured: Week 8
EHS (Erectile Hardness Score) - Week 16
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Measured: Week 16
EHS (Erectile Hardness Score) - Week 24
Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Measured: Week 24
LH - Screen
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Measured: Baseline
LH - Week 8
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Measured: Week 8
LH - Week 16
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Measured: Week 16
LH - Week 24
Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Measured: Week 24
FSH - Screen
Lab Values for follicle stimulating hormone
Measured: Baseline
FSH - Week 8
Lab Values for follicle stimulating hormone
Measured: Week 8
FSH - Week 16
Lab Values for follicle stimulating hormone
Measured: Week 16
FSH - Week 24
Lab Values for follicle stimulating hormone
Measured: Week 24
Free Testosterone - Screen
Measure of Free Testosterone
Measured: Baseline
Free Testosterone - Week 8
Measure of Free Testosterone
Measured: Week 8
Free Testosterone - Week 16
Measure of Free Testosterone
Measured: Week 16
Free Testosterone - Week 24
Measure of Free Testosterone
Measured: Week 24
Estradiol - Screen
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24
Measured: Baseline
Estradiol - Week 8
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Measured: Week 8
Estradiol - Week 16
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Measured: Week 16
Estradiol - Week 24
Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Measured: Week 24
SHBG - Screen
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Measured: Baseline
SHBG - Week 8
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Measured: Week 8
SHBG - Week 16
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Measured: Week 16
SHBG - Week 24
Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Measured: Week 24
SEP #1-3 Cumulative - Screen
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Measured: Baseline
SEP #1-3 Cumulative - Week 8
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Measured: Week 8
SEP #1-3 Cumulative - Week 16
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Measured: Week 16
SEP #1-3 Cumulative - Week 24
Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.
0-3: cumulative score from SEP questions 1, 2, and 3
Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start2 Apr 2015
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
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.
- Other trials for Hypogonadism, MaleStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Robert C Welliver, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933618
- Sponsor's protocol ID
- 4134
- Acronym
- CAP
- Status last verified
- Oct 2019
- First submitted
- 29 Apr 2019
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales
- ClinicalTrials.gov ID
- NCT03933618
- Acronym / sponsor ID
- CAP / 4134
- Conditions
- Hypogonadism, Male
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- Laboratory Corporation of America
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.
Detailed description
Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels. Using these medications, we can obtain therapeutic testosterone levels with either an increase or decrease in estradiol levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| anastrazole-clomiphene-placebo | Other | Drug: Anastrozole 1mg, Drug: Clomiphene Citrate 25mg, Drug: Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks |
| anastrazole-placebo-clomiphene | Other | Drug: Anastrozole 1mg, Drug: Clomiphene Citrate 25mg, Drug: Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks |
| clomiphene-anastrazole-placebo | Other | Drug: Anastrozole 1mg, Drug: Clomiphene Citrate 25mg, Drug: Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks |
| clomiphene-placebo-anastrazole | Other | Drug: Anastrozole 1mg, Drug: Clomiphene Citrate 25mg, Drug: Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks |
| placebo-clomiphene-anastrazole | Other | Drug: Anastrozole 1mg, Drug: Clomiphene Citrate 25mg, Drug: Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks |
| placebo-anastrazole-clomiphene | Other | Drug: Anastrozole 1mg, Drug: Clomiphene Citrate 25mg, Drug: Placebo - Capplacebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men age 18-70
- Baseline morning Testosterone 150-350 ng/dL x2
- leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
- Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
- Body mass index (BMI) <40
Key exclusion criteria (18 listed)
- Current or previous history of prostate cancer
- Previous or current androgen deprivation therapy for prostate cancer,
- Past surgical history of prostatectomy.
- History of testicular cancer.
- History of deep vein thrombosis (DVT) or blood dyscrasia
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 |
|---|---|---|
| Anastrozole 1mg | Drug | anastrazole-clomiphene-placebo, anastrazole-placebo-clomiphene, clomiphene-anastrazole-placebo, clomiphene-placebo-anastrazole, placebo-anastrazole-clomiphene, placebo-clomiphene-anastrazole |
| Clomiphene Citrate 25mg | Drug | anastrazole-clomiphene-placebo, anastrazole-placebo-clomiphene, clomiphene-anastrazole-placebo, clomiphene-placebo-anastrazole, placebo-anastrazole-clomiphene, placebo-clomiphene-anastrazole |
| Placebo - Cap | Drug | anastrazole-clomiphene-placebo, anastrazole-placebo-clomiphene, clomiphene-anastrazole-placebo, clomiphene-placebo-anastrazole, placebo-anastrazole-clomiphene, placebo-clomiphene-anastrazole |
Primary outcome
IIEF (International Index of Erectile Function) Score - Screen
Time frame: At baseline
15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 8
Time frame: Week 8
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 16
Time frame: Week 16
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 24
Time frame: Week 24
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
36 secondary outcomes
Normalized Testosterone - Screen
Time frame: Baseline
Normalized Testosterone - Week 8
Time frame: Week 8
Normalized Testosterone - Week 16
Time frame: Week 16
Normalized Testosterone - Week 24
Time frame: Week 24
ADAM (Androgen Deficiency in the Aging Male) Score - Screen
Time frame: Baseline
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
Time frame: Week 8
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
Time frame: Week 16
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
Time frame: Week 24
EHS (Erectile Hardness Score) - Screen
Time frame: Baseline
EHS (Erectile Hardness Score) - Week 8
Time frame: Week 8
EHS (Erectile Hardness Score) - Week 16
Time frame: Week 16
EHS (Erectile Hardness Score) - Week 24
Time frame: Week 24
LH - Screen
Time frame: Baseline
LH - Week 8
Time frame: Week 8
LH - Week 16
Time frame: Week 16
LH - Week 24
Time frame: Week 24
FSH - Screen
Time frame: Baseline
FSH - Week 8
Time frame: Week 8
FSH - Week 16
Time frame: Week 16
FSH - Week 24
Time frame: Week 24
Free Testosterone - Screen
Time frame: Baseline
Free Testosterone - Week 8
Time frame: Week 8
Free Testosterone - Week 16
Time frame: Week 16
Free Testosterone - Week 24
Time frame: Week 24
Estradiol - Screen
Time frame: Baseline
Estradiol - Week 8
Time frame: Week 8
Estradiol - Week 16
Time frame: Week 16
Estradiol - Week 24
Time frame: Week 24
SHBG - Screen
Time frame: Baseline
SHBG - Week 8
Time frame: Week 8
SHBG - Week 16
Time frame: Week 16
SHBG - Week 24
Time frame: Week 24
SEP #1-3 Cumulative - Screen
Time frame: Baseline
SEP #1-3 Cumulative - Week 8
Time frame: Week 8
SEP #1-3 Cumulative - Week 16
Time frame: Week 16
SEP #1-3 Cumulative - Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert C Welliver, MD principal investigator
Albany Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anastrozole 1mg and Clomiphene Citrate 25mg in people with Hypogonadism, Male, run by Albany Medical College.
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 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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 18 Nov 2019). 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?
IIEF (International Index of Erectile Function) Score - Screen (time frame: At baseline). The study lists 4 primary outcomes in all. 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 18 Nov 2019.