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The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprolide Acetate 3M Depot 11.25 mg | Experimental | Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart. |
|
| Leuprolide Acetate 3M Depot 30 mg | Experimental | Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide Acetate 3 Month Depot | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36. | Day 1, Months 6, 12, 24, and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1) | The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bacher, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 13521 | Birmingham | Alabama | 35233 | United States | ||
| Site Reference ID/Investigator# 14922 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24926950 | Derived | Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P. 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. J Clin Endocrinol Metab. 2014 Sep;99(9):3153-9. doi: 10.1210/jc.2013-4471. Epub 2014 Jun 13. |
| Label | URL |
|---|---|
| Related Info | View source |
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At the end of the Treatment Period, participants who completed the study or prematurely discontinued from the study could enter the Safety Follow-Up Period.
Participants who successfully completed and showed maintenance of luteinizing hormone suppression through the 6-month treatment period of the lead-in study L-CP07-167 (NCT00635817) received the same treatment in this study that they were previously assigned in the lead-in study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprolide Acetate 3M Depot 11.25 mg | Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (36 Months) |
|
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| Day 1, Months 3, 6, 9, 12, and 24 |
| Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) | The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36. | Months 6, 9, 12, 24, 30, and 36 |
| Percentage of Male Participants With Suppression of Basal Testosterone | The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36. | Day 1, Months 3, 6, 9, 12, 24, 30, and 36 |
| Mean Peak-stimulated Luteinizing Hormone Concentration by Visit | Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36. | Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36 |
| Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) | The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36. | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) | The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36. | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| Change From Baseline in Growth Rate | Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit. | Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36 |
| Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age | Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula: (BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline). | Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36 |
| Long Beach |
| California |
| 90806 |
| United States |
| Site Reference ID/Investigator# 26043 | Los Angeles | California | 90027 | United States |
| Site Reference ID/Investigator# 20802 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 22425 | Greenwood Village | Colorado | 80111 | United States |
| Site Reference ID/Investigator# 18181 | Jacksonville | Florida | 32207 | United States |
| Site Reference ID/Investigator# 26364 | Pensacola | Florida | 32504 | United States |
| Site Reference ID/Investigator# 26983 | Indianapolis | Indiana | 46202 | United States |
| Site Reference ID/Investigator# 20821 | Shreveport | Louisiana | 71130-3932 | United States |
| Site Reference ID/Investigator# 23643 | Minneapolis | Minnesota | 55455 | United States |
| Site Reference ID/Investigator# 23502 | Saint Paul | Minnesota | 55102 | United States |
| Site Reference ID/Investigator# 14121 | Kansas City | Missouri | 64108 | United States |
| Site Reference ID/Investigator# 23802 | Oklahoma City | Oklahoma | 73104 | United States |
| Site Reference ID/Investigator# 13324 | Tulsa | Oklahoma | 74135 | United States |
| Site Reference ID/Investigator# 16506 | Hershey | Pennsylvania | 17033 | United States |
| Site Reference ID/Investigator# 14024 | Seattle | Washington | 98104 | United States |
| Site Reference ID/Investigator# 23182 | Bayamón | 00960 | Puerto Rico |
| Site Reference ID/Investigator# 21721 | Ponce | 00717-2116 | Puerto Rico |
| Site Reference ID/Investigator# 25908 | Rio Piedras | 00935 | Puerto Rico |
| Site Reference ID/Investigator# 23082 | San Juan | 00936-8344 | Puerto Rico |
| Leuprolide Acetate 3M Depot 30 mg |
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-up Period (12 Weeks) |
|
|
Participants who received at least 1 dose of study drug in this extension study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Leuprolide Acetate 3M Depot 11.25 mg | Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart. |
| BG001 | Leuprolide Acetate 3M Depot 30 mg | Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone | Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36. | Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, & did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, Months 6, 12, 24, and 36 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1) | The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36. | Intention-to-treat female population. N = the number of participants with available data at each time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, Months 3, 6, 9, 12, and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) | The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36. | Intention-to-treat female population. N = the number of participants with available data at each time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Months 6, 9, 12, 24, 30, and 36 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Male Participants With Suppression of Basal Testosterone | The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36. | Intention-to-treat male population. N = the number of participants with available data at each time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1, Months 3, 6, 9, 12, 24, 30, and 36 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Peak-stimulated Luteinizing Hormone Concentration by Visit | Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36. | Intention-to-treat. N = the number of participants with available data at each time point. | Posted | Mean | Standard Deviation | mIU/mL | Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) | The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36. | Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) | The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36. | Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Growth Rate | Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit. | Intention-to-treat with available growth rate data. N = participants with available data at each time point. | Posted | Mean | Standard Deviation | cm/year | Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age | Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula: (BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline). | Intention-to-treat with available bone age data. N = participants with available data at each time point. | Posted | Mean | Standard Deviation | ratio | Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36 |
|
|
37 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leuprolide Acetate 3M Depot 11.25 mg | Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart. | 1 | 34 | 31 | 34 | ||
| EG001 | Leuprolide Acetate 3M Depot 30 mg | Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. | 0 | 38 | 31 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EAR PAIN | Ear and labyrinth disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| MYOPIA | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| BODY TINEA | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
| |
| EXCORIATION | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA Version 15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| RESPIRATORY DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
| |
| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie, (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Month 12 [N=31, 32] |
|
| Month 24 [N=16, 18] |
|
| Month 36 [N=9, 11] |
|
| Final Visit [N=33, 36] |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|