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

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 17? estradiol (OBE), or transdermal 17? 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 17? 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.

SUBMITTER: Shah S

PROVIDER: S-EPMC4074834 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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

Shah Sejal S Forghani Nikta N Durham Eileen E Neely E Kirk EK

International journal of pediatric endocrinology 20140620 1

<h4>Background</h4>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 transderma ...[more]

PMID: 24982681

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Project description:BackgroundSlowing the decline in participation in physical activity among adolescent girls is a public health priority. This study reports the outcomes from a multi-component school-based intervention (Girls in Sport), focused on promoting physical activity among adolescent girls.MethodsGroup randomized controlled trial in 24 secondary schools (12 intervention and 12 control). Assessments were conducted at baseline (2009) and at 18 months post-baseline (2010). The setting was secondary schools in urban, regional and rural areas of New South Wales, Australia. All girls in Grade 8 in 2009 who attended these schools were invited to participate in the study (N?=?1769). Using a Health Promoting Schools and Action Learning Frameworks, each school formed a committee and developed an action plan for promoting physical activity among Grade 8 girls. The action plan incorporated strategies in three main areas - i) the formal curriculum, ii) school environment, and iii) home/school/community links - based on the results of formative data from target girls and staff and on individual needs of the school. A member of the research team supported each school throughout the intervention. The main outcome measure was accelerometer-derived total physical activity (TPA) spent in physical activity. Data were analyzed from December 2011 to March 2012.Results1518 girls (mean age 13.6y ±0.02) were assessed at baseline. There was a significant decline in TPA from baseline to 18-month follow-up with no differences between girls in the intervention and control schools. Only one-third of schools (4/12) implemented the intervention as per their action plan. Per-protocol analyses on these schools revealed a smaller decline in percentage of time spent in MVPA among girls in the intervention group (adjusted difference 0.5%, 95% CI?=?-0.01, 0.99, P?=?0.05).ConclusionsThe Girls in Sport intervention was not effective in reducing the decline in physical activity among adolescent girls. Lack of implementation by most intervention schools was the main reason for a null effect. Identifying strategies to enhance implementation levels is critical to determining the true potential of this intervention approach.Trial registrationThis study was retrospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12610001077055 . Date of registration: 7 December 2010.

Project description:Tobacco dependence is a chronic, relapsing condition that may require extended treatment.To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers.Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156)Academic center.568 adult smokers.In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks).The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence.At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment.The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected.Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy.National Institutes of Health.

Project description:Importance:Sexual dysfunction, an important determinant of women's health and quality of life, is commonly associated with declining estrogen levels around the menopausal transition. Objective:To determine the effects of oral or transdermal estrogen therapy vs placebo on sexual function in postmenopausal women. Design, Setting, and Participants:Ancillary study of the Kronos Early Estrogen Prevention Study (KEEPS), a 4-year prospective, randomized, double-blinded, placebo-controlled trial of menopausal hormone therapy in healthy, recently menopausal women. Of 727 KEEPS enrollees, 670 agreed to participate in this multicenter ancillary study. Women were 42 to 58 years old, within 36 months from last menstrual period. Data were collected from July 2005 through June 2008 and analyzed from July 2010 through June 2017. Interventions:Women were randomized to either 0.45 mg/d oral conjugated equine estrogens (o-CEE), 50 µg/d transdermal 17?-estradiol (t-E2), or placebo. Participants also received 200 mg oral micronized progesterone (if randomized to o-CEE or t-E2) or placebo (if randomized to placebo estrogens) for 12 days each month. Main Outcomes and Measures:Aspects of sexual function and experience (desire, arousal, lubrication, orgasm, satisfaction, and pain) were assessed using the Female Sexual Function Inventory (FSFI; range, 0-36 points; higher scores indicate better sexual function). Low sexual function (LSF) was defined as an FSFI overall score of less than 26.55. Distress related to low FSFI score (required for the diagnosis of sexual dysfunction) was not evaluated. Results:The 670 participants had a mean (SD) age of 52.7 (2.6) years. The t-E2 treatment was associated with a significant yet moderate improvement in the FSFI overall score across all time points compared with placebo (average efficacy, 2.6; 95% CI, 1.11-4.10; adjusted P?=?.002). With o-CEE treatment, there was no significant difference in FSFI overall score compared with placebo (mean efficacy, 1.4; 95% CI, -0.1 to 2.8; adjusted P?=?.13). There was no difference in FSFI overall score between the t-E2 and o-CEE groups on average across 48 months (adjusted P?=?.22). In the individual domains of sexual function, t-E2 treatment was associated with a significant increase in mean lubrication (0.61; 95% CI, 0.25-0.97; P?=?.001) and decreased pain (0.67; 95% CI, 0.25-1.09; P?=?.002) compared with placebo. Overall, the proportion of women with LSF was significantly lower after t-E2 treatment compared with placebo (67%; 95% CI, 55%-77% vs 76%; 95% CI, 67%-83%; P?=?.04). For o-CEE there was no significant reduction in the odds of LSF. Conclusions and Relevance:Treatment with t-E2 modestly improved sexual function in early postmenopausal women, but whether it relieved symptoms of distress is not known. Trial Registration:clinicaltrials.gov Identifier: NCT00154180.

Project description:BackgroundEarly adolescence is a critical window for intervention when it is possible to lay a foundation for a safe transition to adulthood, before negative outcomes occur. The Adolescent Girls Initiative-Kenya randomized trial tested the effects of combinations of interventions for young adolescent girls in two sites - the Kibera informal settlement in Nairobi and rural Wajir County in the Northeastern region.MethodsThe interventions included community dialogues on the role and value of girls (violence prevention), a conditional cash transfer (education), weekly group meetings for girls with health and life skills training (health), and training and incentives for financial literacy and savings activities (wealth creation). Participants were randomized to one of four study arms: 1) violence prevention only, 2) violence prevention and education, 3) violence prevention, education and health or 4) violence prevention, education, health and wealth creation. An intent-to-treat (ITT) analysis was conducted using longitudinal data to estimate the impact of each combination of interventions and various sensitivity analyses conducted addressing potential attrition bias and multiple hypothesis testing concerns.ResultsIn Kibera, the education conditional cash transfer had small effects on grade attainment but larger impacts on completion of primary school and the transition to secondary school in the most comprehensive arm; the health intervention improved sexual and reproductive health knowledge and condom self-efficacy; and the wealth intervention improved financial literacy and savings behavior. In Wajir, the education conditional cash transfer increased school enrollment and grade attainment, and the wealth intervention improved savings behavior.ConclusionsThe results indicate that when trying to improve a range of outcomes related to adolescent wellbeing for young girls, a multisectoral intervention with components addressing household economic constraints is a promising approach.Trial registrationTrial Registry: ISRCTN, ISRCTN77455458 . Registered 24/12/2015 - Retrospectively registered.

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

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

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