Abstract
BackgroundAdolescent 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 design20 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.ResultsMean (±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.ConclusionsTreatment 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 registrationClinical Trials Identifier: NCT01023178.
Highlights
Adolescent females with ovarian failure require estrogen therapy for induction of puberty and other important physiologic effects
Twenty adolescent females were enrolled during the study time period (OCEE n = 8; Oral 17β estradiol (OBE) n = 7; Transdermal 17β estradiol (TBE) n = 5) (Figure 1, Table 1)
There were no significant differences in baseline biochemical markers between the 3 groups, except for serum glucose concentration, which was not considered clinically significant
Summary
Adolescent females with ovarian failure require estrogen therapy for induction of puberty and other important physiologic effects. Since adolescents with ovarian failure will need estrogen therapy for a prolonged period of time, investigating potential differences between oral and transdermal preparations is important and necessary. In hypogonadal young adult women increasing doses of oral estrogen are associated with decreasing intima media thickness, increasing high-density lipoprotein (HDL) levels, and decreasing plasma glucose levels [3]. These effects need to be weighed against the potentially prothrombotic effects of estrogen highlighted by the Women’s Health Initiative (WHI) [4]. Use of oral 17β estradiol (OBE) in adult females has had variable effects [12], suggesting that OCEE itself may have inflammatory or metabolic effects independent of the route of estrogen delivery, as it is composed of many different forms of estrogen (primarily estrone)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
