NCT01023178

Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure

Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.

Detailed description

Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.

Conditions

• Ovarian Failure, Premature

Interventions

Type	Name	Description
DRUG	17beta Estradiol	Oral pill given daily at increasing doses every 6 months for 18 months.
DRUG	Conjugated estrogens	Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
DRUG	17Beta Estradiol - transdermal	Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
DRUG	Progesterone, micronized	Given starting at 18 months

Timeline

• Start date: 2007-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2009-12-02
• Last updated: 2017-01-20
• Results posted: 2017-01-20

Locations

1 site across 1 country: United States