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The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.
This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old.
At the treatment visits, efficacy assessments are Tanner staging (suppression of breast development in females and genital development in males), gonadotropins (LH and FSH), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lupron (leuprolide acetate) | Drug | Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years). | Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) | Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years). | Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations | Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years. | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) | Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristof Chwalisz, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 46673 | Phoenix | Arizona | 85006 | United States | ||
| Site Reference ID/Investigator# 46671 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21860633 | Derived | Lee PA, Neely EK, Fuqua J, Yang D, Larsen LM, Mattia-Goldberg C, Chwalisz K. Efficacy of Leuprolide Acetate 1-Month Depot for Central Precocious Puberty (CPP): Growth Outcomes During a Prospective, Longitudinal Study. Int J Pediatr Endocrinol. 2011;2011(1):7. doi: 10.1186/1687-9856-2011-7. Epub 2011 Jul 12. |
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This study included 1 treatment group and subjects were assigned the initial dosage depending on their weight. The minimum starting dose was 7.5 mg every 28 days. Study drug was discontinued either when puberty occurred at 12 years +- 6 months for males and 11 years +- 6 months for females or at the discretion of the investigator.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprolide Acetate 1 Month Depot | Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Leuprolide Acetate 1 Month Depot | Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit. |
| 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 | Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years). | The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females (breast development suppression). Study drug was discontinued at the initiation of puberty. | Posted | Number | Percentage of subjects | Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
|
Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued.
Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
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 1 Month Depot | Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aggravation reaction | General disorders | COSTART | COSTART body system is body as a whole |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | COSTART | COSTART body system is body as a whole |
Study drug was discontinued usually at the initiation of puberty (12 years for males and 11 years for females) with the concurrence of the investigator, or at the discretion of the investigator. Adverse events are coded with the COSTART dictionary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott Laboratories | 800-633-9110 |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Mean Stimulated Estradiol Concentrations in Females | Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years. | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
| Mean Stimulated Testosterone Concentrations in Males | Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years. | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
| Mean Ratio of Bone Age to Chronological Age | Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age. | Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
| Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males) |
| Mean Time to or Mean Age at Regular Menses in Females After Treatment | Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment. | Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels) |
| Number of Female Subjects Who Reported Regular Menses at Adulthood | Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding. | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) |
| Number of Subjects Who Reported Pregnancies at Final Questionnaire | The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant. | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) |
| Number of Pregnancies Reported by Subjects at Final Questionnaire | The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported. | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) |
| San Francisco |
| California |
| 94122 |
| United States |
| Site Reference ID/Investigator# 14921 | Stanford | California | 94305 | United States |
| Site Reference ID/Investigator# 14343 | Aurora | Colorado | 80045 | United States |
| Site Reference ID/Investigator# 14341 | St. Petersburg | Florida | 33701 | United States |
| Site Reference ID/Investigator# 14342 | Indianapolis | Indiana | 46202 | United States |
| Site Reference ID/Investigator# 46672 | Baltimore | Maryland | 21201 | United States |
| Site Reference ID/Investigator# 46668 | Springfield | Massachusetts | 01199 | United States |
| Site Reference ID/Investigator# 14344 | Hershey | Pennsylvania | 17033 | United States |
| Noncompliance with visit schedule |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | subjects |
|
Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
|
|
| Secondary | Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations | Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years. | The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females and 6 males. Study drug was discontinued at the initiation of puberty. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
|
|
|
| Secondary | Mean Stimulated Estradiol Concentrations in Females | Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years. | All females in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty. | Posted | Mean | Standard Error | pg/mL | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
|
|
|
| Secondary | Mean Stimulated Testosterone Concentrations in Males | Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years. | All males in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty. | Posted | Mean | Standard Deviation | ng/dL | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
|
|
|
| Secondary | Mean Ratio of Bone Age to Chronological Age | Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age. | The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty. | Posted | Mean | Standard Deviation | ratio | Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
|
|
|
| Other Pre-specified | Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) | Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males. | For the follow-up posttreatment period, the ITT population=40 subjects and the safety population=55 subjects who received at least 1 injection of study drug during the treatment period. Study drug was discontinued at the initiation of puberty. The mean age of subjects at final questionnaire completion was 24.76 years with a range of 18.87 to 26.66. | Posted | Mean | Standard Error | cm | Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males) |
|
|
|
| Other Pre-specified | Mean Time to or Mean Age at Regular Menses in Females After Treatment | Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment. | During the posttreatment period, data were obtained from 32 female subjects. Twenty-seven subjects reported the start of menses, but only 26 subjects reported a menses start date. | Posted | Mean | Standard Deviation | years | Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels) |
|
|
|
| Other Pre-specified | Number of Female Subjects Who Reported Regular Menses at Adulthood | Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding. | A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire. | Posted | Number | Subjects | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) |
|
|
|
| Other Pre-specified | Number of Subjects Who Reported Pregnancies at Final Questionnaire | The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant. | A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire. | Posted | Number | Subjects | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) |
|
|
|
| Other Pre-specified | Number of Pregnancies Reported by Subjects at Final Questionnaire | The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported. | A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire. | Posted | Number | Pregnancies | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) |
|
|
|
| Primary | Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) | Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years). | The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 6 males (genital development suppression). Study drug was discontinued at the initiation of puberty. | Posted | Number | Percentage of subjects | Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit |
|
|
|
| 7 |
| 55 |
| 52 |
| 55 |
| Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | COSTART body system is body as a whole |
|
| Infection | Infections and infestations | COSTART | COSTART body system is body as a whole |
|
| Heart arrest | Cardiac disorders | COSTART | COSTART body system is cardiovascular system |
|
| Bone Disorder | Musculoskeletal and connective tissue disorders | COSTART | COSTART body system is musculoskeletal system |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | COSTART | COSTART body system is musculoskeletal system |
|
| Personality disorder | Psychiatric disorders | COSTART | COSTART body system is nervous system |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | COSTART | COSTART body system is respiratory system |
|
| Pneumonia | Infections and infestations | COSTART | COSTART body system is respiratory system |
|
| Repair of ventriculoperitoneal shunt | Surgical and medical procedures | COSTART | COSTART body system was not classified since it was a surgical repair. |
|
| Accidental injury | Injury, poisoning and procedural complications | COSTART | COSTART body system is body as a whole |
|
| Allergic reaction | Immune system disorders | COSTART | COSTART body system is body as a whole |
|
| Asthenia | General disorders | COSTART | COSTART body system is body as a whole |
|
| Body odor | Skin and subcutaneous tissue disorders | COSTART | COSTART body system is body as a whole |
|
| Fever | General disorders | COSTART | COSTART body system is body as a whole |
|
| Flu syndrome | Infections and infestations | COSTART | COSTART body system is body as a whole |
|
| Headache | Nervous system disorders | COSTART | COSTART body system is body as a whole |
|
| Infection | Infections and infestations | COSTART | COSTART body system is body as a whole |
|
| Injection site pain | General disorders | COSTART | COSTART body system is body as a whole |
|
| Injection site reaction | General disorders | COSTART | COSTART body system is body as a whole |
|
| Pain | General disorders | COSTART | COSTART body system is body as a whole |
|
| Reaction unevaluable | General disorders | COSTART | COSTART body system is body as a whole |
|
| Vasodilatation | Vascular disorders | COSTART | COSTART body system is cardiovascular system |
|
| Diarrhea | Gastrointestinal disorders | COSTART | COSTART body system is digestive system |
|
| Dyspepsia | Gastrointestinal disorders | COSTART | COSTART body system is digestive system |
|
| Increased appetite | Metabolism and nutrition disorders | COSTART | COSTART body system is digestive system |
|
| Nausea | Gastrointestinal disorders | COSTART | COSTART body system is digestive system |
|
| Vomiting | Gastrointestinal disorders | COSTART | COSTART body system is digestive system |
|
| Lymphadenopathy | Blood and lymphatic system disorders | COSTART | COSTART body system is hemic and lymphatic system |
|
| Edema | General disorders | COSTART | COSTART body system is metabolic and nutritional disorders |
|
| Growth retarded | Musculoskeletal and connective tissue disorders | COSTART | COSTART body system is metabolic and nutritional disorders |
|
| Weight gain | Investigations | COSTART | COSTART body system is metabolic and nutritional disorders |
|
| Weight loss | Investigations | COSTART | COSTART body system is metabolic and nutritional disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | COSTART | COSTART body system is musculoskeletal system |
|
| Myalgia | Musculoskeletal and connective tissue disorders | COSTART | COSTART body system is musculoskeletal system |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | COSTART | COSTART body system is musculoskeletal system |
|
| Depression | Psychiatric disorders | COSTART | COSTART body system is nervous system |
|
| Dizziness | Nervous system disorders | COSTART | COSTART body system is nervous system |
|
| Emotional Lability | Psychiatric disorders | COSTART | COSTART body system is nervous system |
|
| Nervousness | Psychiatric disorders | COSTART | COSTART body system is nervous system |
|
| Cough increased | Respiratory, thoracic and mediastinal disorders | COSTART | COSTART body system is respiratory system |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | COSTART | COSTART body system is respiratory system |
|
| Pharyngitis | Infections and infestations | COSTART | COSTART body system is respiratory system |
|
| Rhinitis | Infections and infestations | COSTART | COSTART body system is respiratory system |
|
| Sinusitis | Infections and infestations | COSTART | COSTART body system is respiratory system |
|
| Acne | Skin and subcutaneous tissue disorders | COSTART | COSTART body system is skin and appendages |
|
| Herpes zoster | Infections and infestations | COSTART | COSTART body system is skin and appendages |
|
| Hirsutism | Skin and subcutaneous tissue disorders | COSTART | COSTART body system is skin and appendages |
|
| Pruritus | Skin and subcutaneous tissue disorders | COSTART | COSTART body system is skin and appendages |
|
| Rash | Skin and subcutaneous tissue disorders | COSTART | COSTART body system is skin and appendages |
|
| Skin disorder | Skin and subcutaneous tissue disorders | COSTART | COSTART body system is skin and appendages |
|
| Urticaria | Skin and subcutaneous tissue disorders | COSTART | COSTART body system is skin and appendages |
|
| Ear pain | Ear and labyrinth disorders | COSTART | COSTART body system is special senses |
|
| Eye disorder | Eye disorders | COSTART | COSTART body system is special senses |
|
| Otitis media | Infections and infestations | COSTART | COSTART body system is special senses |
|
| Leukorrhea | Reproductive system and breast disorders | COSTART | COSTART body system is urogenital system |
|
| Menstrual disorder | Reproductive system and breast disorders | COSTART | COSTART body system is urogenital system |
|
| Urinary tract infection | Infections and infestations | COSTART | COSTART body system is urogenital system |
|
| Vaginitis | Infections and infestations | COSTART | COSTART body system is urogenital system |
|
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
| 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 |
|
| Peak stimulated LH at Week 24 N = 53 |
|
| Peak stimulated LH at Week 48 N = 54 |
|
| Peak stimulated LH at Week 96 N = 46 |
|
| Peak stimulated LH at Week 144 N = 36 |
|
| Peak stimulated LH at Week 192 N = 20 |
|
| Peak stimulated LH at Week 240 N = 17 |
|
| Peak stimulated LH at Final Visit N = 55 |
|
| Peak stimulated FSH at Baseline N=55 |
|
| Peak stimulated FSH at Week 4 N = 55 |
|
| Peak stimulated FSH at Week 12 N = 54 |
|
| Peak stimulated FSH at Week 24 N = 53 |
|
| Peak stimulated FSH at Week 48 N = 54 |
|
| Peak stimulated FSH at Week 96 N = 46 |
|
| Peak stimulated FSH at Week 144 N = 36 |
|
| Peak stimulated FSH at Week 192 N = 20 |
|
| Peak stimulated FSH at Week 240 N = 17 |
|
| Peak stimulated FSH at Final Visit N = 55 |
|
|
| Mean stimulated estradiol at Week 24 N=47 |
|
| Mean stimulated estradiol at Week 48 N=47 |
|
| Mean stimulated estradiol at Week 96 N=39 |
|
| Mean stimulated estradiol at Week 144 N=31 |
|
| Mean stimulated estradiol at Week 192 N=15 |
|
| Mean stimulated estradiol at Week 240 N=13 |
|
| Mean stimulated estradiol at Final Visit N=49 |
|
|
| Mean stimulated testosterone at Week 24 N=6 |
|
| Mean stimulated testosterone at Week 48 N=6 |
|
| Mean stimulated testosterone at Week 96 N=6 |
|
| Mean stimulated testosterone at Week 144 N=5 |
|
| Mean stimulated testosterone at Week 192 N=4 |
|
| Mean stimulated testosterone at Week 240 N=3 |
|
| Mean stimulated testosterone at Final Visit N=6 |
|
| Title | Measurements |
|---|---|
|
| Ratio at Week 96 N=44 |
|
| Ratio at Week 144 N=31 |
|
| Ratio at Week 192 N=26 |
|
| Ratio at Week 240 N=16 |
|
| Ratio at Final Visit N=53 |
|
|
| Final adult ht.gain from predicted ht. at BL N=17 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Genital development suppression - Week 144 N=4 |
|
| Genital development suppression - Week 192 N=4 |
|
| Genital development suppression - Week 240 N=3 |
|
| Genital development suppression - Final Visit N=6 |
|