ISRCTN11469487CompletedPhase 2
The aromatase inhibitor anastrozole combined to the LHRH analogue leuprorelin vs leuprorelin alone in ameliorating predicted adult height In girls with early or precosious puberty with a compromised growth potential
Attikon University Hospital0 sites40 target enrollmentStarted: January 13, 2015Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
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)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
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)
Investigators
Similar Trials
Completed
Phase 3
Gynecomastia Extension StudyGynecomastiaNCT00637182AstraZeneca
Unknown
Not Applicable
The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic PregnancyEctopic PregnancyNCT04308343Assiut University120
Terminated
Phase 2
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast CancerBreast NeoplasmsNCT01262274Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan57
Active, not recruiting
Phase 2
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast CancerFemale Breast CarcinomaBreast CancerNCT02942355Wake Forest University Health Sciences40
Terminated
Not Applicable
Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal HysterectomyUTERINE LEIOMYOMANCT01280045University of Sao Paulo5