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A placebo controlled study on the effect of oxandrolone in combination with authentic biosynthetic human growth hormone and low-dose oestrogens on growth and metabolic parameters in girls with Turner's syndrome.

A placebo controlled study on the effect of oxandrolone in combination with authentic biosynthetic human growth hormone and low-dose oestrogens on growth and metabolic parameters in girls with Turner's syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23518
Enrollment
135
Registered
2005-09-12
Start date
1992-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

girls with Turner syndrome

Interventions

Three arm study: 1) GH alone (plus oestrogens in adolescence)
2) idem plus low-dose oxandrolone (0.03 mg/kg body weight/day
3) idem plus moderate-dose oxandrolone (0.06 mg/kg/day.

Sponsors

Pfizer (New York), previously Pharmacia; and Lilly (Indianapolis, USA)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Turner syndrome, confirmed by chromosomal analysis. 3 age ranges: 2.00-7.99 yrs, 8-11.99 yrs, 12.00-15.99 yrs.

Exclusion criteria

Exclusion criteria: 1. Any other disorder that may affect growth; 2. Hydrocephalus; 3. Other experimental drug study; 4. Drugs that may interfere with GH; 5. Previous treatment with GH or sex steroidsor anabolic steroids; 6. Suspicion of emotional deprivation.

Design outcomes

Primary

MeasureTime frame
Final height.—

Secondary

MeasureTime frame
Potential side effects (glucose intolerance; lowering of the voice); psychosexual changes.—

Contacts

Public ContactNederlandse Groeistichting

Westzeedijk 106

+31 (0)10 2251533

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)