Hypogonadism, HypogonadotropicPhase 2NCT03245827
Hypogonadotropic Hypogonadism in Obese Young Males
A Phase 2 study testing Clomiphene in people with Hypogonadism, Hypogonadotropic, run by Sandeep Singh Dhindsa, M.D., F.A.C.E at 1 site in United States.
Trial summary
Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Hypogonadotropic
- What is being tested?
- Clomiphene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 29 Oct 2021
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- Age 18-30 years inclusive will be recruited.
- A total of 90 males will be recruited:-
- 30 obese males (defined as BMI ≥30 kg/m2) with HH,
- 30 obese males with normal FT concentrations and
- 30 lean males (defined as BMI <25 kg/m2) with normal FT concentrations.
Who cannot join
- Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months
- Hematocrit > 50%
- Congestive heart failure
- currently suffering from depression
- type 1 diabetes
- Hepatic disease (transaminase > 3 times normal) or cirrhosis
Show all 10Show fewer
- Renal impairment (eGFR<30 ml/min/1.73m2)
- HIV or Hepatitis C positive status
- Participation in any other concurrent clinical trial
- currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Trial locations and contacts
1 site in 1 country.
About this study
Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene.
Read the detailed description
The prevalence of obesity has increased in children over the past few decades. Approximately 20% of adolescent boys are now considered obese. It is well accepted that obese children are at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent studies have uncovered yet another undesirable effect of obesity. The testosterone levels of obese boys are only half those of lean boys at completion of puberty. Testosterone is important for muscle and bone development. Men with low testosterone are at higher risk of insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since testosterone is the major reproductive hormone, these obese boys are at risk of decreased fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter, there is a decline in testosterone levels at the rate of 2% per year for the rest of life. Thus there is a clear need to develop a deeper understanding of low testosterone in these males who are entering their peak fertility years. There are no approved treatments for this disorder. The investigators propose to conduct a randomized placebo controlled trial to evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have low testosterone concentrations. Clomiphene is a drug that increases testosterone concentrations and possibly increases sperm production. In contrast, testosterone replacement therapy decreased fertility and cannot be used in young men. Investigators will study the effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study will evaluate:-
- testicular function: Testosterone and two proteins secreted by testis(insulin like factor 3 and inhibin B) will be measured in the blood before and after treatment with clomiphene or placebo.
- insulin resistance: Investigators will measure insulin and glucose levels in the blood.
- inflammation: Investigators will measure proteins that induce inflammation.
- Conditions
- Hypogonadism, Hypogonadotropic
- Being tested
- Clomiphene, Placebo
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClomipheneDrug
Also called active
clomiphene capsule 25mg twice a week
PlaceboDrug
placebo capsule 25mg twice a week
| Study group | Role | What they receive |
|---|---|---|
| Obese males with hypogonadism-active | Active comparator | Subjects will be randomized to receive clomiphene capsules Receives: Drug: Clomiphene |
| Obese males with hypogonadism-placebo | Placebo comparator | Subjects will be randomized to receive placebo capsules Receives: Drug: Placebo |
| Obese males with normal testosterone | No intervention | comparison group |
| lean males with normal testosterone | No intervention | comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Free Testosterone
after clomiphene or placebo treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Apr 2019
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Why it stopped: not enough recruitment
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, HypogonadotropicStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandeep Singh Dhindsa, M.D., F.A.C.E
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sandeep Singh Dhindsa, M.D., F.A.C.E, St. Louis University
- Investigators
- sandeep dhindsa, md, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245827
- Sponsor's protocol ID
- 28389
- Status last verified
- Jun 2022
- First submitted
- 3 Aug 2017
- Last updated
- 29 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypogonadotropic Hypogonadism in Obese Young Males
- ClinicalTrials.gov ID
- NCT03245827
- Acronym / sponsor ID
- 28389
- Conditions
- Hypogonadism, Hypogonadotropic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sandeep Singh Dhindsa, M.D., F.A.C.EUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 29 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene.
Detailed description
The prevalence of obesity has increased in children over the past few decades. Approximately 20% of adolescent boys are now considered obese. It is well accepted that obese children are at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent studies have uncovered yet another undesirable effect of obesity. The testosterone levels of obese boys are only half those of lean boys at completion of puberty. Testosterone is important for muscle and bone development. Men with low testosterone are at higher risk of insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since testosterone is the major reproductive hormone, these obese boys are at risk of decreased fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter, there is a decline in testosterone levels at the rate of 2% per year for the rest of life. Thus there is a clear need to develop a deeper understanding of low testosterone in these males who are entering their peak fertility years. There are no approved treatments for this disorder. The investigators propose to conduct a randomized placebo controlled trial to evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have low testosterone concentrations. Clomiphene is a drug that increases testosterone concentrations and possibly increases sperm production. In contrast, testosterone replacement therapy decreased fertility and cannot be used in young men. Investigators will study the effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study will evaluate:-
- testicular function: Testosterone and two proteins secreted by testis(insulin like factor 3 and inhibin B) will be measured in the blood before and after treatment with clomiphene or placebo.
- insulin resistance: Investigators will measure insulin and glucose levels in the blood.
- inflammation: Investigators will measure proteins that induce inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese males with hypogonadism-active | Active comparator | Drug: ClomipheneSubjects will be randomized to receive clomiphene capsules |
| Obese males with hypogonadism-placebo | Placebo comparator | Drug: PlaceboSubjects will be randomized to receive placebo capsules |
| Obese males with normal testosterone | No intervention | –comparison group |
| lean males with normal testosterone | No intervention | –comparison group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males
- Age 18-30 years inclusive will be recruited.
- A total of 90 males will be recruited:-
- 30 obese males (defined as BMI ≥30 kg/m2) with HH,
- 30 obese males with normal FT concentrations and
Key exclusion criteria (10 listed)
- Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months
- Hematocrit > 50%
- Congestive heart failure
- currently suffering from depression
- type 1 diabetes
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: activeclomiphene capsule 25mg twice a week | Drug | Obese males with hypogonadism-active |
| Placeboplacebo capsule 25mg twice a week | Drug | Obese males with hypogonadism-placebo |
Primary outcome
Serum Free Testosterone
Time frame: 12 weeks
after clomiphene or placebo treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
sandeep dhindsa, md principal investigator
St. Louis University
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, Hypogonadotropic, run by Sandeep Singh Dhindsa, M.D., F.A.C.E 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 29 Jun 2022. 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 29 Jun 2022). 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?
Serum Free Testosterone (time frame: 12 weeks). 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 29 Jun 2022.