Unstimulated Luteinizing Hormone for Assessment of Suppression during Treatment of Central Precocious Puberty with 6-Month Subcutaneous Leuprolide Acetate: Correlations with Clinical Response
Authors' conclusion
Unstimulated LH has value as an efficacy measure and concentrations <1 IU/L may be an adequate surrogate of treatment response in children with CPP. All children who completed the study had evidence of pubertal suppression.
Study context
- Population
- Children with treatment-naïve CPP
- Participants
- 62 children
- Primary endpoint
- Unstimulated LH <1 IU/L as efficacy measure
- Follow-up
- Weeks 24 and 48
Methodological detailssingle-group
- Single-group
Primary result
As reported in the abstract
Achieved unstimulated luteinizing hormone (LH) <1 IU/L, week 24
84%
Achieved unstimulated LH <1 IU/L, week 48
86%
ROC: unstimulated LH as predictor of GnRH-stimulated LH <4 IU/L at weeks 24 and 48, AUC
0.88
Further findings
Children not achieving unstimulated LH <1 IU/L at week 24 who completed the study
- Children
- 8
- All showed lack of pubertal stage progression and stable/decreased bone age (BA)/CA
BA/CA and predicted adult height (PAH), all children · screening to week 48
- Mean BA/CA at screening
- 1.4
- Mean BA/CA at week 48
- 1.3
- Mean PAH increase
- 3 cm
Girls not achieving stimulated LH <4 IU/L at week 24 · week 48
- Girls
- 7
- Increased PAH
- 6/7
- Unstimulated LH <1 IU/L
- 4
- All achieved E2 <10 pg/mL, lacked pubertal stage progression, and had stable or decreased BA/CA
Original publication
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