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01.12.2014 | Research | Ausgabe 1/2014 Open Access

International Journal of Pediatric Endocrinology 1/2014

A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism

Zeitschrift:
International Journal of Pediatric Endocrinology > Ausgabe 1/2014
Autoren:
Sejal Shah, Nikta Forghani, Eileen Durham, E Kirk Neely
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1687-9856-2014-12) contains supplementary material, which is available to authorized users.
Sejal Shah, Nikta Forghani, Eileen Durham and E Kirk Neely contributed equally to this work.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

SS participated in the study coordination, implementation, performed the statistical analysis, and wrote the first draft of the manuscript. NF conceived of the study and participated in its design and coordination and helped to draft and revise the manuscript. ED participated in study coordination and revising the manuscript. EN conceived of the study and participated in its design and coordination and helped to draft and revise the manuscript. All authors read and approved the final manuscript.

Abstract

Background

Adolescent females with ovarian failure require estrogen therapy for induction of puberty and other important physiologic effects. Currently, health care providers have varying practices without evidence-based standards, thus investigating potential differences between oral and transdermal preparations is essential. The purpose of this study was to compare the differential effects of treatment with oral conjugated equine estrogen (OCEE), oral 17β estradiol (OBE), or transdermal 17β estradiol (TBE) on biochemical profiles and feminization in girls with ovarian failure.

Study design

20 prepubertal adolescent females with ovarian failure, ages 12–18 years, were randomized to OCEE (n = 8), OBE (n = 7), or TBE (n = 5) for 24 months. Estrogen replacement was initiated at a low dose (0.15 mg OCEE, 0.25 mg OBE, or 0.0125 mg TBE) and doubled every 6 months to a maximum dose of 0.625 mg/d OCEE, 1 mg/d OBE, or 0.05 mg/d TBE. At 18 months, micronized progesterone was added to induce menstrual cycles. Biochemical markers including sex hormones, inflammatory markers, liver enzymes, coagulation factors, and lipids were obtained at baseline and 6 month intervals. Differences in levels of treatment parameters between the groups were evaluated with one-way analysis of variance (ANOVA). The effect of progesterone on biochemical markers was evaluated with the paired t-test.

Results

Mean (±SE) estradiol levels at maximum estrogen dose (18 months) were higher in the TBE group (53 ± 19 pg/mL) compared to OCEE (14 ± 5 pg/mL) and OBE (12 ± 5 pg/mL) (p ≤ 0.01). The TBE and OBE groups had more effective feminization (100% Tanner 3 breast stage at 18 months). There were no statistical differences in other biochemical markers between treatment groups at 18 months or after the introduction of progesterone.

Conclusions

Treatment with transdermal 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 and TBE provide safe and effective alternatives to OCEE to induce puberty in girls, but larger prospective randomized trials are required.

Trial registration

Clinical Trials Identifier:NCT01023178.
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