Trial · NCT00660010
Study of Lupron Depot In The Treatment of Central Precocious Puberty
NCT00660010, Phase 3, Completed, Abbott; results first posted 2010-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Lupron Depot In The Treatment of Central Precocious Puberty. Trials, record NCT00660010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00660010
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lupron Depot In The Treatment of Central Precocious Puberty
- NCT number
- NCT00660010
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Puberty, Precocious
- Interventions
- Lupron (leuprolide acetate)
- First posted
- 2008-04-17
- Last updated
- 2011-04-12
- Results first posted
- 2010-07-20
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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). |
| Primary | Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) | Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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). |
| Secondary | Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. |
| Secondary | Mean Stimulated Estradiol Concentrations in Females | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. |
| Secondary | Mean Stimulated Testosterone Concentrations in Males | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. |
| Secondary | Mean Ratio of Bone Age to Chronological Age | Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. |
| Other | Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) | 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) | 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. |
| Other | Mean Time to or Mean Age at Regular Menses in Females After Treatment | Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels) | Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment. |
| Other | Number of Female Subjects Who Reported Regular Menses at Adulthood | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) | 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. |
| Other | Number of Subjects Who Reported Pregnancies at Final Questionnaire | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. | mIU/mL | MEAN |
| SECONDARY | Mean Stimulated Estradiol Concentrations in Females | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. | pg/mL | MEAN |
| SECONDARY | Mean Stimulated Testosterone Concentrations in Males | Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. | ng/dL | MEAN |
| SECONDARY | Mean Ratio of Bone Age to Chronological Age | Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit | 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. | ratio | MEAN |
| OTHER_PRE_SPECIFIED | Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) | 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) | 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. | cm | MEAN |
| OTHER_PRE_SPECIFIED | Mean Time to or Mean Age at Regular Menses in Females After Treatment | Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels) | 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. | years | MEAN |
| OTHER_PRE_SPECIFIED | Number of Female Subjects Who Reported Regular Menses at Adulthood | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) | 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. | Subjects | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Subjects Who Reported Pregnancies at Final Questionnaire | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) | 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. | Subjects | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Pregnancies Reported by Subjects at Final Questionnaire | Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age) | 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. | Pregnancies | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Leuprolide Acetate 1 Month Depot | Breast development suppression - Week 4 N=44 | 81.8 | Percentage of subjects | |
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Leuprolide Acetate 1 Month Depot | Breast development suppression-Week 48 N=47 | 80.9 | 66.7 to 90.9 | Percentage of subjects |
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Leuprolide Acetate 1 Month Depot | Breast development suppression -Week 96 N=41 | 87.8 | 73.8 to 95.9 | Percentage of subjects |
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Leuprolide Acetate 1 Month Depot | Breast development suppression-Week 144 N=29 | 82.8 | 64.2 to 94.2 | Percentage of subjects |
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Leuprolide Acetate 1 Month Depot | Breast development suppression - Week 192 N=18 | 66.7 | 41.0 to 86.7 | Percentage of subjects |
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Leuprolide Acetate 1 Month Depot | Breast development suppression -Week 240 N=13 | 76.9 | 46.2 to 95.0 | Percentage of subjects |
| Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) | Leuprolide Acetate 1 Month Depot | Breast development suppression-Final Visit N=48 | 77.1 | Percentage of subjects | |
| Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations | Leuprolide Acetate 1 Month Depot | Peak stimulated LH at Baseline N=55 | 35.0 | Standard Deviation 21.32 | mIU/mL |
| Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations | Leuprolide Acetate 1 Month Depot | Peak stimulated LH at Week 4 N = 55 | 0.8 | Standard Deviation 0.57 | mIU/mL |
| Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations | Leuprolide Acetate 1 Month Depot | Peak stimulated LH at Week 12 N = 54 | 1.1 | Standard Deviation 1.77 | mIU/mL |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leuprolide Acetate 1 Month Depot | 55 | |
| Overall Study | COMPLETED | Leuprolide Acetate 1 Month Depot | 46 | |
| Overall Study | NOT COMPLETED | Leuprolide Acetate 1 Month Depot | 9 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Leuprolide Acetate 1 Month Depot | 16 | 55 | |
| other | Accidental injury | Injury, poisoning and procedural complications | Leuprolide Acetate 1 Month Depot | 16 | 55 | |
| other | Allergic reaction | Immune system disorders | Leuprolide Acetate 1 Month Depot | 6 | 55 | |
| other | Asthenia | General disorders | Leuprolide Acetate 1 Month Depot | 6 | 55 | |
| other | Body odor | Skin and subcutaneous tissue disorders | Leuprolide Acetate 1 Month Depot | 3 | 55 | |
| other | Fever | General disorders | Leuprolide Acetate 1 Month Depot | 14 | 55 | |
| other | Flu syndrome | Infections and infestations | Leuprolide Acetate 1 Month Depot | 19 | 55 | |
| other | Headache | Nervous system disorders | Leuprolide Acetate 1 Month Depot | 25 | 55 | |
| other | Infection | Infections and infestations | Leuprolide Acetate 1 Month Depot | 13 | 55 | |
| other | Injection site pain | General disorders | Leuprolide Acetate 1 Month Depot | 8 | 55 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leuprolide Acetate 1 Month Depot | ||
| Total, other adverse events | Leuprolide Acetate 1 Month Depot | 52 | 55 |
| Total, serious adverse events | Leuprolide Acetate 1 Month Depot | 7 | 55 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21860633 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00660010
GET https://conductscience.org/api/trials/v1/NCT00660010/results?page=2