Hypogonadism, MalePhase 2NCT01904734
Clomid in Men With Low Testosterone With and Without Prior Treatment
A Phase 2 study testing Clomiphene in people with Hypogonadism, Male, run by Phoenix VA Health Care System at 1 site in United States.
Trial summary
This study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- Clomiphene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 31 Oct 2018
- Phase
- Phase 2
- 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 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or eligible for care at Phoenix VA Health Care System
- Male ages 30-70 years
- testosterone level below 250 ng/dl before treatment
- able to provide informed written consent
Who cannot join
- evidence of pituitary tumor >1mm by MRI or CAT scan
- chronic illness (renal, cardiac, liver failure)
- Prostate specific antigen (PSA) >4.0 ng/ml
- history of prostate, breast, or testicular cancer
- eye disease compromising vision (e.g. cataracts)
Trial locations and contacts
1 site in 1 country.
United States1 site
Phoenix VA Health Care System
Phoenix, Arizona, 85012
About this study
Official title: A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone
This study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.
Read the detailed description
Clomiphene, an oral FDA-approved agent for female infertility has been shown to normalize testosterone levels in men with hypogonadotropic hypogonadism. It appears to be safe and well tolerated. This study will compare testosterone responses to clomiphene citrate in male veterans with hypothalamic hypogonadism naïve to treatment with responses of similar patients already receiving treatment with injectable or transdermal testosterone. This is an open-label, prospective, interventional trial to be conducted in an outpatient specialty care setting. We will randomize 64 hypogonadal male veterans evenly divided between naive and previous treatment and treat for 8 weeks with clomid, increasing the initial dose of 25 mg to 50 mg/day in those who fail to achieve target testosterone level (450 ng/dl) after the first 3 weeks. Endpoint measurements performed in the Phoenix VA Health Care System (PVAHCS) clinical laboratory will be total testosterone as well as bioavailable testosterone and sex hormone binding globulin. Total testosterone level at 8 weeks of treatment will be reported as the primary endpoint. Safety measures (CBC,liver functions, PSA) will be assessed at 8 weeks as well. This study will help serve as a guide for design of future studies of clomiphene in hypogonadal men.
- Conditions
- Hypogonadism, Male
- Being tested
- Clomiphene
- Keywords
- testosterone, hypogonadism, pituitary
- Medical subject headings
- Eunuchism, Hypogonadism, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClomipheneDrug
Also called Clomid, Clomiphene citrate
Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| No previous male hormone treatment | Active comparator | Clomiphene Receives: Drug: Clomiphene |
| Previously treated with testosterone | Active comparator | Clomiphene Receives: Drug: Clomiphene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum testosterone
laboratory measurement by standard immunometric method
Measured: at the end of 8 weeks of treatment
Secondary outcomes (2)
Bioavailable testosterone
Non-SHBG bound testosterone by ammonium sulfate precipitation method
Measured: at the end of 8 weeks of treatment
Serum sex hormone binding globulin (SHBG)level
Laboratory measurement of SHBG by standard immunometric technique
Measured: at the end of 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startOct 2012
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix VA Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Sherman M. Harman, Phoenix VA Health Care System
- Investigators
- Sherman M Harman, MD, PhD, Principal investigator, Phoenix VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904734
- Sponsor's protocol ID
- VETSCLOMIDPHX
- Status last verified
- Mar 2021
- First submitted
- 15 Jul 2013
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Moskovic DJ, Katz DJ, Akhavan A, Park K, Mulhall JP. Clomiphene citrate is safe and effective for long-term management of hypogonadism. BJU Int. 2012 Nov;110(10):1524-8. doi: 10.1111/j.1464-410X.2012.10968.x. Epub 2012 Mar 28.
PubMed 22458540Katz DJ, Nabulsi O, Tal R, Mulhall JP. Outcomes of clomiphene citrate treatment in young hypogonadal men. BJU Int. 2012 Aug;110(4):573-8. doi: 10.1111/j.1464-410X.2011.10702.x. Epub 2011 Nov 1.
PubMed 22044663Taylor F, Levine L. Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost. J Sex Med. 2010 Jan;7(1 Pt 1):269-76. doi: 10.1111/j.1743-6109.2009.01454.x. Epub 2009 Aug 17.
PubMed 19694928
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone
- ClinicalTrials.gov ID
- NCT01904734
- Acronym / sponsor ID
- VETSCLOMIDPHX
- Conditions
- Hypogonadism, Male
- Keywords
- testosterone, hypogonadism, pituitary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Phoenix VA Health Care SystemUS federal agency
- Study start
- Oct 2012
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 22 Jul 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.
This study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.
Detailed description
Clomiphene, an oral FDA-approved agent for female infertility has been shown to normalize testosterone levels in men with hypogonadotropic hypogonadism. It appears to be safe and well tolerated. This study will compare testosterone responses to clomiphene citrate in male veterans with hypothalamic hypogonadism naïve to treatment with responses of similar patients already receiving treatment with injectable or transdermal testosterone. This is an open-label, prospective, interventional trial to be conducted in an outpatient specialty care setting. We will randomize 64 hypogonadal male veterans evenly divided between naive and previous treatment and treat for 8 weeks with clomid, increasing the initial dose of 25 mg to 50 mg/day in those who fail to achieve target testosterone level (450 ng/dl) after the first 3 weeks. Endpoint measurements performed in the Phoenix VA Health Care System (PVAHCS) clinical laboratory will be total testosterone as well as bioavailable testosterone and sex hormone binding globulin. Total testosterone level at 8 weeks of treatment will be reported as the primary endpoint. Safety measures (CBC,liver functions, PSA) will be assessed at 8 weeks as well. This study will help serve as a guide for design of future studies of clomiphene in hypogonadal men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No previous male hormone treatment | Active comparator | Drug: ClomipheneClomiphene |
| Previously treated with testosterone | Active comparator | Drug: ClomipheneClomiphene |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient or eligible for care at Phoenix VA Health Care System
- Male ages 30-70 years
- testosterone level below 250 ng/dl before treatment
- able to provide informed written consent
Key exclusion criteria (5 listed)
- evidence of pituitary tumor >1mm by MRI or CAT scan
- chronic illness (renal, cardiac, liver failure)
- Prostate specific antigen (PSA) >4.0 ng/ml
- history of prostate, breast, or testicular cancer
- eye disease compromising vision (e.g. cataracts)
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 |
|---|---|---|
| ClomipheneAlso: Clomid, Clomiphene citrateStart with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks | Drug | No previous male hormone treatment, Previously treated with testosterone |
Primary outcome
Total serum testosterone
Time frame: at the end of 8 weeks of treatment
laboratory measurement by standard immunometric method
2 secondary outcomes
Bioavailable testosterone
Time frame: at the end of 8 weeks of treatment
Serum sex hormone binding globulin (SHBG)level
Time frame: at the end of 8 weeks of treatment
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 10 Mar 2021.
- Background: PubMed 22458540Moskovic DJ, Katz DJ, Akhavan A, Park K, Mulhall JP. Clomiphene citrate is safe and effective for long-term management of hypogonadism. BJU Int. 2012 Nov;110(10):1524-8. doi: 10.1111/j.1464-410X.2012.10968.x. Epub 2012 Mar 28.
- Background: PubMed 22044663Katz DJ, Nabulsi O, Tal R, Mulhall JP. Outcomes of clomiphene citrate treatment in young hypogonadal men. BJU Int. 2012 Aug;110(4):573-8. doi: 10.1111/j.1464-410X.2011.10702.x. Epub 2011 Nov 1.
- Background: PubMed 19694928Taylor F, Levine L. Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost. J Sex Med. 2010 Jan;7(1 Pt 1):269-76. doi: 10.1111/j.1743-6109.2009.01454.x. Epub 2009 Aug 17.
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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.
Sherman M Harman, MD, PhD principal investigator
Phoenix VA Health Care System
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 Clomiphene in people with Hypogonadism, Male, run by Phoenix VA Health Care System 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 4 inclusion and 5 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 10 Mar 2021. 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 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?
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?
Total serum testosterone (time frame: at the end of 8 weeks of treatment). 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 NCT01904734, which also lists 3 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 10 Mar 2021.