Phase 3 Completed N=11 Diagnostic

Growth Hormone Use in Adults With Prader-Willi Syndrome

Prader–Willi syndrome

Source: ClinicalTrials.gov NCT00444964 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Jan 2021

Primary outcomePrimary: Body Composition — 51.2; 48.5; 52.1 percentage of body fat — p=<0.05

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months.

Outcome Measures

Outcome	Result	p-value
PRIMARY Body Composition	51.2; 48.5; 52.1	<0.05 sig
PRIMARY Blood Chemistry	93; 385; 140	<0.05 sig
PRIMARY Physical Activity	177; 256; 215	<0.05 sig

Eligibility Criteria

Inclusion Criteria

16 to 60 years old
Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR)
Low IGF-1 level (e.g.,≤25%) at baseline
Ability to provide informed consent or availability of a suitable legally authorized representative

Exclusion Criteria

Pregnancy
Previous treatment with growth hormone
Uncontrolled endocrine disease, (i.e. diabetes or thyroid)
History of severe scoliosis
Heart disease
Uncontrolled high blood pressure or history of stroke
Morbid obesity (using PWS growth charts)
Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00444964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.