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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MH083657-05A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The investigators are investigating whether a hormone that is naturally produced by the human body, called testosterone, can help improve weight, disordered eating, depression, and anxiety. The investigators hypothesize that testosterone will be a novel and effective endocrine-targeted therapy for patients with anorexia nervosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Active Comparator | Testosterone x 24 weeks |
|
| Placebo | Placebo Comparator | Placebo x 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Testosterone 300mcg transdermal patch x 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weight | Weight in kilograms | Baseline, 24 Weeks |
| Change From Baseline in Depression Symptom Severity | Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23) | Baseline, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Klibanski, MD | Massachusetts General Hospital | Principal Investigator |
| Karen K Miller, MD | Massachusetts General Hospital | Study Director |
| Erinne Meenaghan, NP | Massachusetts General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02144 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36798485 | Derived | Plessow F, Galbiati F, Eddy KT, Misra M, Miller KK, Klibanski A, Aulinas A, Lawson EA. Low oxytocin levels are broadly associated with more pronounced psychopathology in anorexia nervosa with primarily restricting but not binge/purge eating behavior. Front Endocrinol (Lausanne). 2023 Jan 31;13:1049541. doi: 10.3389/fendo.2022.1049541. eCollection 2022. | |
| 31219558 | Derived | Kimball A, Schorr M, Meenaghan E, Bachmann KN, Eddy KT, Misra M, Lawson EA, Kreiger-Benson E, Herzog DB, Koman S, Keane RJ, Ebrahimi S, Schoenfeld D, Klibanski A, Miller KK. A Randomized Placebo-Controlled Trial of Low-Dose Testosterone Therapy in Women With Anorexia Nervosa. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4347-4355. doi: 10.1210/jc.2019-00828. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone | Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. |
| FG001 | Placebo | Placebo x 24 weeks Placebo: Placebo transdermal patch x 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone | Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks |
| BG001 | Placebo | Placebo x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. Placebo: Placebo transdermal patch x 24 weeks |
| 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 | Change From Baseline in Weight | Weight in kilograms | All subjects who received at least one dose of study medication | Posted | Mean | Standard Deviation | kilograms | Baseline, 24 Weeks |
|
24 weeks
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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 | Testosterone | Testosterone x 24 weeks Testosterone: Testosterone 300mcg transdermal patch x 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to anorexia nervosa | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne or Increase in acne | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event data collected at each study visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Klibanski | Massachusetts General Hospital | 6177263870 | aklibanski@partners.org |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001068 | Feeding and Eating Disorders |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo |
| Drug |
Placebo transdermal patch x 24 weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change From Baseline in Depression Symptom Severity | Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23) | All subjects who received at least one dose of study medication | Posted | Mean | Standard Deviation | HAM-D score on a scale | Baseline, 24 weeks |
|
|
|
| 0 |
| 43 |
| 4 |
| 43 |
| 33 |
| 43 |
| EG001 | Placebo | Placebo x 24 weeks Placebo: Placebo transdermal patch x 24 weeks | 0 | 47 | 1 | 47 | 33 | 47 |
| Hospitalization due to exacerbation of GI disorders | Gastrointestinal disorders | Systematic Assessment |
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| Hospitalization due to depression exacerbation | Psychiatric disorders | Systematic Assessment |
|
|
| Patch site irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event data collected at each study visit. |
|
| Oily skin or Increase in oily skin | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event data collected at each study visit. |
|
| Hirsutism or Increased hair growth | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event data collected at each study visit. |
|
| Depilation | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event data collected at each study visit. |
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
| 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 |