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Study of Lupron Depot In The Treatment of Central Precocious Puberty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00660010
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : July 20, 2010
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Abbott

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Puberty, Precocious
Intervention Drug: Lupron (leuprolide acetate)
Enrollment 55
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 55
Completed 46
Not Completed 9
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             3
Adverse Event             1
Noncompliance with visit schedule             3
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
<=18 years
55
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
6.9  (1.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
49
  89.1%
Male
6
  10.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Subjects
United States Number Analyzed 55 participants
55
1.Primary Outcome
Title Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)
Hide Description 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).
Time Frame Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Percentage of subjects
Breast development suppression - Week 4 N=44 81.8
Breast development suppression-Week 48 N=47 80.9
Breast development suppression -Week 96 N=41 87.8
Breast development suppression-Week 144 N=29 82.8
Breast development suppression - Week 192 N=18 66.7
Breast development suppression -Week 240 N=13 76.9
Breast development suppression-Final Visit N=48 77.1
2.Primary Outcome
Title Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)
Hide Description 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).
Time Frame Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Percentage of subjects
Genital development suppression - Week 4 N=5 80.0
Genital development suppression - Week 48 N=6 83.3
Genital development suppression - Week 96 N=6 83.3
Genital development suppression - Week 144 N=4 75.0
Genital development suppression - Week 192 N=4 75.0
Genital development suppression - Week 240 N=3 66.7
Genital development suppression - Final Visit N=6 83.3
3.Secondary Outcome
Title Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations
Hide Description 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.
Time Frame Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Peak stimulated LH at Baseline N=55 35.0  (21.32)
Peak stimulated LH at Week 4 N = 55 0.8  (0.57)
Peak stimulated LH at Week 12 N = 54 1.1  (1.77)
Peak stimulated LH at Week 24 N = 53 0.8  (0.79)
Peak stimulated LH at Week 48 N = 54 0.6  (0.47)
Peak stimulated LH at Week 96 N = 46 0.4  (0.33)
Peak stimulated LH at Week 144 N = 36 0.4  (0.24)
Peak stimulated LH at Week 192 N = 20 0.4  (0.25)
Peak stimulated LH at Week 240 N = 17 0.4  (0.62)
Peak stimulated LH at Final Visit N = 55 0.8  (3.29)
Peak stimulated FSH at Baseline N=55 13.3  (5.58)
Peak stimulated FSH at Week 4 N = 55 0.9  (0.44)
Peak stimulated FSH at Week 12 N = 54 1.1  (0.61)
Peak stimulated FSH at Week 24 N = 53 1.2  (0.84)
Peak stimulated FSH at Week 48 N = 54 1.2  (0.58)
Peak stimulated FSH at Week 96 N = 46 1.4  (0.79)
Peak stimulated FSH at Week 144 N = 36 1.4  (0.73)
Peak stimulated FSH at Week 192 N = 20 1.3  (0.76)
Peak stimulated FSH at Week 240 N = 17 1.4  (0.67)
Peak stimulated FSH at Final Visit N = 55 1.7  (1.73)
4.Secondary Outcome
Title Mean Stimulated Estradiol Concentrations in Females
Hide Description 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.
Time Frame Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 49
Mean (Standard Error)
Unit of Measure: pg/mL
Mean stimulated estradiol at baseline N=49 15.3  (18.73)
Mean stimulated estradiol at Week 4 N=48 5.0  (0.00)
Mean stimulated estradiol at Week 12 N=47 6.0  (6.56)
Mean stimulated estradiol at Week 24 N=47 5.0  (0.00)
Mean stimulated estradiol at Week 48 N=47 5.0  (0.00)
Mean stimulated estradiol at Week 96 N=39 5.0  (0.00)
Mean stimulated estradiol at Week 144 N=31 5.0  (0.00)
Mean stimulated estradiol at Week 192 N=15 5.0  (0.00)
Mean stimulated estradiol at Week 240 N=13 5.0  (0.00)
Mean stimulated estradiol at Final Visit N=49 5.0  (0.14)
5.Secondary Outcome
Title Mean Stimulated Testosterone Concentrations in Males
Hide Description 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.
Time Frame Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng/dL
Mean stimulated testosterone at baseline N=6 347.7  (121.86)
Mean stimulated testosterone at Week 4 N=6 18.0  (12.39)
Mean stimulated testosterone at Week 12 N=6 14.2  (7.05)
Mean stimulated testosterone at Week 24 N=6 13.8  (6.15)
Mean stimulated testosterone at Week 48 N=6 17.3  (11.64)
Mean stimulated testosterone at Week 96 N=6 24.8  (19.92)
Mean stimulated testosterone at Week 144 N=5 21.6  (19.50)
Mean stimulated testosterone at Week 192 N=4 24.0  (17.19)
Mean stimulated testosterone at Week 240 N=3 25.3  (24.01)
Mean stimulated testosterone at Final Visit N=6 24.2  (17.16)
6.Secondary Outcome
Title Mean Ratio of Bone Age to Chronological Age
Hide Description 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.
Time Frame Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: ratio
Ratio at Baseline N=53 1.5  (0.30)
Ratio at Week 24 N=53 1.5  (0.25)
Ratio at Week 48 N=51 1.4  (0.18)
Ratio at Week 96 N=44 1.3  (0.15)
Ratio at Week 144 N=31 1.2  (0.12)
Ratio at Week 192 N=26 1.2  (0.11)
Ratio at Week 240 N=16 1.2  (0.10)
Ratio at Final Visit N=53 1.2  (0.11)
7.Other Pre-specified Outcome
Title Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 40
Mean (Standard Error)
Unit of Measure: cm
Near final adult ht. standardized score N=33 -0.2  (1.20)
Near final ht.gain from predicted ht. at BL N=29 3.2  (5.37)
Final adult ht.standardized score N=19 0.0  (1.13)
Final adult ht.gain from predicted ht. at BL N=17 3.9  (5.05)
8.Other Pre-specified Outcome
Title Mean Time to or Mean Age at Regular Menses in Females After Treatment
Hide Description Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment.
Time Frame Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: years
Time to regular menses 1.5  (0.53)
Age at regular menses 12.9  (0.89)
9.Other Pre-specified Outcome
Title Number of Female Subjects Who Reported Regular Menses at Adulthood
Hide Description 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.
Time Frame Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Subjects
No. of subjects with regular menses as adults 16
No. of subjects without regular menses as adults 4
10.Other Pre-specified Outcome
Title Number of Subjects Who Reported Pregnancies at Final Questionnaire
Hide Description 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.
Time Frame Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Subjects
Number of subjects who reported being pregnant 7
Number of subjects who were currently pregnant 1
11.Other Pre-specified Outcome
Title Number of Pregnancies Reported by Subjects at Final Questionnaire
Hide Description The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported.
Time Frame Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Pregnancies
Number of pregnancies 12
Number of live births 6
Number of miscarriages 5
Time Frame 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 Event Reporting Description 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.
 
Arm/Group Title Leuprolide Acetate 1 Month Depot
Hide Arm/Group Description 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.
All-Cause Mortality
Leuprolide Acetate 1 Month Depot
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Leuprolide Acetate 1 Month Depot
Affected / at Risk (%)
Total   7/55 (12.73%) 
Cardiac disorders   
Heart arrest 1 [1]  1/55 (1.82%) 
General disorders   
Aggravation reaction 1 [2]  1/55 (1.82%) 
Infections and infestations   
Infection 1 [2]  1/55 (1.82%) 
Pneumonia 1 [3]  1/55 (1.82%) 
Musculoskeletal and connective tissue disorders   
Bone Disorder 1 [4]  1/55 (1.82%) 
Pathological fracture 1 [4]  1/55 (1.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoma 1 [2]  1/55 (1.82%) 
Psychiatric disorders   
Personality disorder 1 [5]  1/55 (1.82%) 
Respiratory, thoracic and mediastinal disorders   
Asthma 1 [3]  1/55 (1.82%) 
Surgical and medical procedures   
Repair of ventriculoperitoneal shunt 1 [6]  1/55 (1.82%) 
1
Term from vocabulary, COSTART
[1]
COSTART body system is cardiovascular system
[2]
COSTART body system is body as a whole
[3]
COSTART body system is respiratory system
[4]
COSTART body system is musculoskeletal system
[5]
COSTART body system is nervous system
[6]
COSTART body system was not classified since it was a surgical repair.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Leuprolide Acetate 1 Month Depot
Affected / at Risk (%)
Total   52/55 (94.55%) 
Blood and lymphatic system disorders   
Lymphadenopathy 1 [1]  3/55 (5.45%) 
Ear and labyrinth disorders   
Ear pain 1 [2]  4/55 (7.27%) 
Eye disorders   
Eye disorder 1 [2]  3/55 (5.45%) 
Gastrointestinal disorders   
Abdominal pain 1 [3]  16/55 (29.09%) 
Diarrhea 1 [4]  9/55 (16.36%) 
Dyspepsia 1 [4]  5/55 (9.09%) 
Nausea 1 [4]  7/55 (12.73%) 
Vomiting 1 [4]  13/55 (23.64%) 
General disorders   
Asthenia 1 [3]  6/55 (10.91%) 
Fever 1 [3]  14/55 (25.45%) 
Injection site pain 1 [3]  8/55 (14.55%) 
Injection site reaction 1 [3]  3/55 (5.45%) 
Pain 1 [3]  12/55 (21.82%) 
Reaction unevaluable 1 [3]  5/55 (9.09%) 
Edema 1 [5]  4/55 (7.27%) 
Immune system disorders   
Allergic reaction 1 [3]  6/55 (10.91%) 
Infections and infestations   
Flu syndrome 1 [3]  19/55 (34.55%) 
Infection 1 [3]  13/55 (23.64%) 
Pharyngitis 1 [6]  29/55 (52.73%) 
Rhinitis 1 [6]  14/55 (25.45%) 
Sinusitis 1 [6]  11/55 (20.00%) 
Herpes zoster 1 [7]  8/55 (14.55%) 
Otitis media 1 [2]  15/55 (27.27%) 
Urinary tract infection 1 [8]  4/55 (7.27%) 
Vaginitis 1 [8]  11/55 (20.00%) 
Injury, poisoning and procedural complications   
Accidental injury 1 [3]  16/55 (29.09%) 
Investigations   
Weight gain 1 [5]  9/55 (16.36%) 
Weight loss 1 [5]  3/55 (5.45%) 
Metabolism and nutrition disorders   
Increased appetite 1 [4]  5/55 (9.09%) 
Musculoskeletal and connective tissue disorders   
Growth retarded 1 [5]  6/55 (10.91%) 
Arthralgia 1 [9]  3/55 (5.45%) 
Myalgia 1 [9]  4/55 (7.27%) 
Pathological fracture 1 [9]  4/55 (7.27%) 
Nervous system disorders   
Headache 1 [3]  25/55 (45.45%) 
Dizziness 1 [10]  4/55 (7.27%) 
Psychiatric disorders   
Depression 1 [10]  3/55 (5.45%) 
Emotional Lability 1 [10]  15/55 (27.27%) 
Nervousness 1 [10]  4/55 (7.27%) 
Reproductive system and breast disorders   
Leukorrhea 1 [8]  4/55 (7.27%) 
Menstrual disorder 1 [8]  3/55 (5.45%) 
Respiratory, thoracic and mediastinal disorders   
Cough increased 1 [6]  17/55 (30.91%) 
Epistaxis 1 [6]  6/55 (10.91%) 
Skin and subcutaneous tissue disorders   
Body odor 1 [3]  3/55 (5.45%) 
Acne 1 [7]  15/55 (27.27%) 
Hirsutism 1 [7]  3/55 (5.45%) 
Pruritus 1 [7]  3/55 (5.45%) 
Rash 1 [7]  18/55 (32.73%) 
Skin disorder 1 [7]  6/55 (10.91%) 
Urticaria 1 [7]  4/55 (7.27%) 
Vascular disorders   
Vasodilatation 1 [11]  6/55 (10.91%) 
1
Term from vocabulary, COSTART
[1]
COSTART body system is hemic and lymphatic system
[2]
COSTART body system is special senses
[3]
COSTART body system is body as a whole
[4]
COSTART body system is digestive system
[5]
COSTART body system is metabolic and nutritional disorders
[6]
COSTART body system is respiratory system
[7]
COSTART body system is skin and appendages
[8]
COSTART body system is urogenital system
[9]
COSTART body system is musculoskeletal system
[10]
COSTART body system is nervous system
[11]
COSTART body system is cardiovascular system
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott Laboratories
Phone: 800-633-9110
Responsible Party: Kristof Chwalisz, MD, PhD Therapeutic Area Head, Abbott
ClinicalTrials.gov Identifier: NCT00660010     History of Changes
Other Study ID Numbers: M90-516
First Submitted: April 15, 2008
First Posted: April 17, 2008
Results First Submitted: April 22, 2010
Results First Posted: July 20, 2010
Last Update Posted: April 12, 2011