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

Stanford University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Failure, Premature

Interventions

17beta EstradiolDRUG

Oral pill given daily at increasing doses every 6 months for 18 months.

Conjugated estrogensDRUG

Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months

17Beta Estradiol - transdermalDRUG

Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: in whom initiation of estrogen therapy has been recommended due to ovarian failure * Outpatients * age \>=12 years to 17.99 years old Exclusion Criteria: * spontaneous menses * significant concurrent medical problem including: * Liver function tests (LFTs) 3 times normal * clotting disorder * ongoing cancer treatment

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Estradiol

Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.

Time frame: end of study (up to 2 years)

Data from ClinicalTrials.gov

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