Hypogonadotropic HypogonadismPhase 1NCT03118479
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
A Phase 1 study testing Anastrozole Pill and Testosterone in people with Hypogonadotropic Hypogonadism and Kallmann Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadotropic Hypogonadism, Kallmann Syndrome
- What is being tested?
- Anastrozole Pill and Testosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 1 Sep 2010
- Phase
- Phase 1
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
- mean testosterone level less than 300 ng/dl
- stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)
- normal serum TSH
- normal serum prolactin levels
Who cannot join
- Type 2 diabetes mellitus
- history of diabetes in parents
- sleep apnea
- bleeding disorder
- seeking fertility
- 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age 60.
- history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident.
- illicit drug use/alcohol use (>4 drinks per day)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism
The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).
The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.
- Conditions
- Hypogonadotropic Hypogonadism, Kallmann Syndrome
- Being tested
- Anastrozole Pill, Testosterone, Placebo Oral Tablet
- Keywords
- IHH, KS, Idiopathic hypogonadotropic hypogonadism, GnRH deficiency
- Medical subject headings
- Hypogonadism, Kallmann Syndrome, Idiopathic Hypogonadotropic Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastrozole PillDrug
Also called Arimidex (anastrozole)
10 mg of Anastrozole to be taken daily for 3 months.
TestosteroneDrug
Also called Androgel
Androgel 7.5 g to be applied transdermally daily for 3 months.
Placebo Oral TabletDrug
One tablet to be taken daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Androgen only addback | Experimental | Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. Receives: Drug: Anastrozole Pill; Drug: Testosterone |
| Combined sex steroid addback | Experimental | Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. Receives: Drug: Testosterone; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance
Response to 75 g glucose load
Measured: Change between baseline and 3 months
Change in insulin sensitivity
IV glucose tolerance test
Measured: Change between baseline and 3 months
Secondary outcomes (2)
Change in visceral fat
Assessed by CT of abdomen
Measured: Change between baseline and 3 months
Change in resting energy expenditure
Assessed by metabolic monitor
Measured: Change between baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startMay 2010
- Primary completion1 Sep 2010
- Study completion1 Sep 2010
Why it stopped: Because the PI left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances Hayes, Massachusetts General Hospital
- Investigators
- Nelly Pitteloud, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118479
- Sponsor's protocol ID
- 2009 - P - 001874
- Status last verified
- Apr 2017
- First submitted
- 14 Jul 2010
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT03118479
- Acronym / sponsor ID
- 2009 - P - 001874
- Conditions
- Hypogonadotropic Hypogonadism, Kallmann Syndrome
- Keywords
- IHH, KS, Idiopathic hypogonadotropic hypogonadism, GnRH deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the PI left the institution.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- 1 Sep 2010 (actual)
- Study completion
- 1 Sep 2010 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).
The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Androgen only addback | Experimental | Drug: Anastrozole Pill, Drug: TestosteroneAnastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. |
| Combined sex steroid addback | Experimental | Drug: Testosterone, Drug: Placebo Oral TabletPlacebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
- mean testosterone level less than 300 ng/dl
- stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)
- normal serum TSH
- normal serum prolactin levels
Key exclusion criteria (8 listed)
- Type 2 diabetes mellitus
- history of diabetes in parents
- sleep apnea
- bleeding disorder
- seeking fertility
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 PillAlso: Arimidex (anastrozole)10 mg of Anastrozole to be taken daily for 3 months. | Drug | Androgen only addback |
| TestosteroneAlso: AndrogelAndrogel 7.5 g to be applied transdermally daily for 3 months. | Drug | Androgen only addback, Combined sex steroid addback |
| Placebo Oral TabletOne tablet to be taken daily for 3 months | Drug | Combined sex steroid addback |
Primary outcome
Change in glucose tolerance
Time frame: Change between baseline and 3 months
Response to 75 g glucose load
Change in insulin sensitivity
Time frame: Change between baseline and 3 months
IV glucose tolerance test
2 secondary outcomes
Change in visceral fat
Time frame: Change between baseline and 3 months
Change in resting energy expenditure
Time frame: Change between baseline and 3 months
Results and safety
The study was stopped early (reason given: Because the PI left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
Related trials for Hypogonadotropic Hypogonadism
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
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.
Nelly Pitteloud, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anastrozole Pill and Testosterone in people with Hypogonadotropic Hypogonadism and Kallmann Syndrome, run by Massachusetts General Hospital 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 5 inclusion and 8 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 18 Apr 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Because the PI left the institution.). Results are not available in the source record.
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?
Change in glucose tolerance (time frame: Change between baseline and 3 months). The study lists 2 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 Apr 2017.