Initiating Transdermal Estradiol Therapy in Turner's Syndrome
Summary
This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of estradiol administered by recently available transdermal patches for the initiation of puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH) therapy. The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment, low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating feminization, height velocity, and bone mineral density without compromising growth potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone in effects on feminization, height velocity, and bone mineral density.
Timeline
- Start
- 2009-04
- Primary completion
- 2011-03
- Completion
- 2011-03
Outcome
Outcome not reported
Stopped (Enrollment): “Poor accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 14 ug | Other |
| Subject | Estradiol | Other / unclassified | 25 ug | Other |
| Background | Somatropin | Protein / enzyme biologic | 0.05 mg/kg | — |