drugset / Trial / NCT00870220
Initiating Transdermal Estradiol Therapy in Turner's Syndrome
Phase 1
Terminated
1 enrolled
University of Chicago
Johns Hopkins University · collabMassachusetts General Hospital · collabNovo Nordisk A/S · collabThomas Jefferson University · collabUniversity of Michigan · collabUniversity of Oklahoma · collabUniversity of South Florida · collab
NaSingle-groupSingle-blindTreatment
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
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 | — |