Conditions: Ovarian Failure, Premature
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 17Beta Estradiol - transdermal arm 2: Conjugated estrogens arm 3: 17beta Estradiol

Interventions: intervention 1: 17beta Estradiol intervention 2: Conjugated estrogens intervention 3: 17Beta Estradiol - transdermal intervention 4: Progesterone, micronized
Intervention descriptions: intervention 1: Oral pill given daily at increasing doses every 6 months for 18 months. intervention 2: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months intervention 3: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months intervention 4: Given starting at 18 months

Protocol document: