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Not able meet target enrollment.
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Obesity is associated with an increase in blood levels of estrogen. Estrogen or "female hormone" is believed to have a negative effect on sperm production. Aromatase inhibitors such as anastrozole work to decrease the production of estrogen and increase testosterone in the body. By decreasing the level of estrogen, sperm production should improve. In this study, the investigators will try to determine the benefit of anastrozole in obese men and follow pregnancy outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Placebo Comparator | Placebo |
|
| Group A | Experimental | Anastrozole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole | Drug | 1 mg qd for 4 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | Partner pregnancy rate during study participation | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad O Hammoud, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo once daily |
| FG001 | Anastrozole | 1 milligram daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo once daily |
| BG001 | Anastrozole | 1 milligram daily |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pregnancy Rate | Partner pregnancy rate during study participation | Posted | Number | participants partner | 4 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Axillary Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Liver Enzymes | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Gibson | University of Utah | 801-213-2845 | marie.gibson@hsc.utah.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009845 | Oligospermia |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Placebo | Drug | Placebo Comparator |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 10 |
| 3 |
| 20 |
| EG001 | Anastrozole | 1 milligram daily | 1 | 10 | 7 | 20 |
| Headache | General disorders |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |