Aromatase inhibitors in girls: Anastrozole combined to the LHRH analogue leuprorelin in Girls with early or precocious puberty and a compromised growth potential
Phase 2
Completed
- Conditions
- Compromised predicted adult height in girls with early or precocious pubertyNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN11469487
- Lead Sponsor
- Attikon University Hospital
- Brief Summary
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26507391 results 2020 Results article in https://doi.org/10.1210/jendso/bvaa046.1757 (added 08/02/2023) 2024 Other publications in https://doi.org/10.3389/fendo.2024.1366970 results from the second phase of the GAIL study (added 17/04/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
1. Idiopathic precocious (breast development < 7.5 yrs) or early puberty (breast development 7.5-9 yrs)
2. Previously naïve to any hormonal therapy
3. PAH lower than -2 SDS or -1.5 SDS lower than their target height (mid parental height -6.5 cm)
Exclusion Criteria
1. Organic precocious puberty
2. Syndromic, systemic or hereditary conditions that either impair growth or associate with PP
3. Bone diseases related to short stature (i.e. hypochondroplasia)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method