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Aromatase inhibitors in girls: Anastrozole combined to the LHRH analogue leuprorelin in Girls with early or precocious puberty and a compromised growth potential

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11469487
Enrollment
40
Registered
2015-01-13
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compromised predicted adult height in girls with early or precocious puberty Nutritional, Metabolic, Endocrine

Interventions

An initial phase IIa trial with 5 girls on the combined treatment for 1 year was performed. Girls with idiopathic precocious (<7.5yrs) or early (7.5-9yrs) puberty, all with a PAH lower than -2 or mor

Sponsors

Attikon University Hospital
Lead Sponsor
Athens Medical Center
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
1. Predicted adult height calculated according to the Bayley Pinneau tables with a bone age calculated according to the atlas of Greulich and Pyle, at 6-12-18-24 months. 2. Height velocity 3. Height for bone age 4. Bone age advancement 5. BMI Participants are followed until bone age reaches 14 or near adult height is achieved.

Secondary

MeasureTime frame
1. Potential hyperandrogenism (clinical or biochemical) 2. Ovarian cyst formation (pelvic ultrasound) 3. Bone mineral density (evaluated yearly by DXA) 4. Radiological evaluation of the lumbar spine (yearly) 5. Reports of peculiar behavior

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026