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Because the PI left the institution.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androgen only addback | Experimental | Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. |
|
| Combined sex steroid addback | Experimental | Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole Pill | Drug | 10 mg of Anastrozole to be taken daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose tolerance | Response to 75 g glucose load | Change between baseline and 3 months |
| Change in insulin sensitivity | IV glucose tolerance test | Change between baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visceral fat | Assessed by CT of abdomen | Change between baseline and 3 months |
| Change in resting energy expenditure | Assessed by metabolic monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelly Pitteloud, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Testosterone | Drug | Androgel 7.5 g to be applied transdermally daily for 3 months. |
|
|
| Placebo Oral Tablet | Drug | One tablet to be taken daily for 3 months |
|
| Change between baseline and 3 months |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D017436 | Kallmann Syndrome |
| C562785 | Idiopathic Hypogonadotropic Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D058490 | Disorder of Sex Development, 46,XY |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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