Could transdermal estradiol+progesterone be a safer postmenopausal HRT? A review

L’Hermite, Marc; Simoncini, Tommaso; Fuller, Sarah; Genazzani, Andrea Riccardo

doi:10.1016/j.maturitas.2008.07.007

Cited by 79 publications

(48 citation statements)

References 220 publications

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“…Transdermal ERT has minimal, if any, effect on hepatic clotting factor production and other protein changes associated with the liver first-pass effect. Whereas oral ERT in postmenopausal women is associated with an increased risk of deep vein thrombosis and pulmonary thromboembolism [20,21,22], breast cancer [23], reduced insulin-like growth factor-I levels, increased fat mass and reduced lean body mass [24], none of these effects are evident with transdermal ERT. Furthermore, studies on physiological sex steroid replacement therapy (transdermal E 2 and progesterone) in postmenopausal women and women with premature ovarian failure resulted in lower blood pressure and improved renal function compared to oral regimens [22,25].…”

Section: Discussionmentioning

confidence: 99%

“…Whereas oral ERT in postmenopausal women is associated with an increased risk of deep vein thrombosis and pulmonary thromboembolism [20,21,22], breast cancer [23], reduced insulin-like growth factor-I levels, increased fat mass and reduced lean body mass [24], none of these effects are evident with transdermal ERT. Furthermore, studies on physiological sex steroid replacement therapy (transdermal E 2 and progesterone) in postmenopausal women and women with premature ovarian failure resulted in lower blood pressure and improved renal function compared to oral regimens [22,25]. Transdermal ERT in girls with TS has shown a faster bone accrual in the spine, increased uterine growth, improved overall body composition and lower luteinizing hormone/follicle-stimulating hormone concentrations compared to oral ERT [17,26,27].…”

Section: Discussionmentioning

confidence: 99%

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Physiological Estrogen Replacement Therapy for Puberty Induction in Girls: A Clinical Observational Study

2014

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Background/Aim: The goal of estrogen replacement therapy (ERT) in girls with hypogonadism is to achieve the endocrine milieu similar to natural puberty, where transdermal administration is the most physiological route. The aim of the study was to evaluate guidelines for the induction of puberty with transdermal estradiol (E₂) patches in a large outpatient setting. Methods: In a retrospective study, serum E₂ levels from 18 clinics were analyzed at the Göteborg Pediatric Growth Research Center laboratory, as part of the initiation of ERT in girls with hypogonadism. Exclusion criteria were pubertas tarda and pubertal arrest. Eighty-eight observations (50 with Turner syndrome, TS) were included. Serum E₂ levels were determined by extraction + radioimmunoassay (detection limit 4 pmol/l) and analyzed in relation to the dose of Evorel® (25 µg/24 h, containing 1.60 mg estradiol hemihydrate; Janssen-Cilag Pharmaceutica N.V., Beerse, Belgium). Results: There was a linear relationship between serum E₂ and the weight-based dose, with r = 0.56, p < 0.0001 for all observations and r = 0.59, p < 0.0001 for the TS study group. Linear regression analysis for doses of 0.05-0.07 µg/kg resulted in serum levels of 17-23 pmol/l (TS 17-24 pmol/l) and doses of 0.08-0.12 µg/kg in 26-39 pmol/l (TS 27-39 pmol/l). Conclusions: For the initiation of ERT with nocturnally administered E₂ patches, we recommend reduced starting doses of 0.05-0.07 µg/kg, with the goal of mimicking E₂ levels during gonadarche. In older girls, when breast development is of high priority, the starting dose can still be 0.08-0.12 µg/kg.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Physiological Estrogen Replacement Therapy for Puberty Induction in Girls: A Clinical Observational Study

2014

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“…27 claiM 2: coMpounding provides iMproved delivery and toleraBility oF Ht Compounded medications require a written prescription from a licensed physician. Prescriptions filled in a compounding pharmacy are prepared, mixed, and assembled according to the specifications of the prescriber.…”

Section: Claims About Cbht Claim 1: Compounded Bht Is Safer Than Fda-mentioning

confidence: 99%

“…38 It is unknown whether the increased risk of breast cancer in the E+P arm of the WHI vs the estrogen-only arm was the result of the addition of a progestin, the specific combination and dosage of E+P that was used in the trial, or the specific type of progestin (MPA) that was used. 27 For many clinicians, the preferred progesterone formulation has been Prometrium (Abbott Laboratories, Abbott Park, IL), the FDA-approved, micronized formulation of oral progesterone, because it is identical to endogenous progesterone and has improved bioavailability. 38 In an observational study, a decreased risk of histology-and hormone receptor-defined invasive breast cancer was noted with use of a combination of micronized progesterone and estrogen vs the use of synthetic progestogens; however, further study is needed to establish long-term safety.…”

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confidence: 99%

Bioidentical Hormone Therapy

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Pruthi

2011

Mayo Clinic Proceedings

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The change in hormonal milieu associated with perimenopause and menopause can lead to a variety of symptoms that can affect a woman's quality of life. Postmenopausal hormone therapy (HT) is an effective, well-tolerated treatment for these symptoms. However, combined HT consisting of conjugated equine estrogen and medroxyprogesterone acetate has been associated with an increased number of health risks when compared with conjugated equine estrogen alone or placebo. As a result, some women are turning to alternative hormonal formulations known as compounded bioidentical HT because they perceive them to be a safer alternative. This article defines compounded bioidentical HT and explores the similarities and differences between it and US Food and Drug Administration-approved HT. We will examine the major claims made by proponents of compounded bioidentical HT and recommend strategies for management of patients who request bioidentical HT from physicians. The change in hormonal milieu associated with perimenopause and menopause can lead to a wide variety of symptoms that may negatively affect a woman's quality of life. The most common symptoms include hot flashes, night sweats, emotional lability, poor concentration, and sleep disturbance; these can range from mild to severe. Postmenopausal hormone therapy (HT) is an effective, well-tolerated treatment for menopausal symptoms. In the United States, a number of US Food and Drug Administration (FDA)-approved hormone preparations are available for treatment of women with menopausal symptoms.2 In 2002, results from the estrogen plus progestin (E+P) arm of the Women's Health Initiative (WHI) revealed an increased risk of breast cancer, cardiovascular disease, stroke, and thromboembolic events in women taking conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) compared with those in the placebo group.3 These findings prompted many women to discontinue HT or to seek a safer alternative to FDA-approved HT for treatment of menopausal symptoms. As a result of the WHI, many women ask their physicians for non-FDA-approved compounded bioidentical HT (CBHT), which is also known as natural HT, believing that it is safer than FDA-approved therapy. 3,4 It is estimated that CBHT is a multibillion-dollar industry, possibly affecting millions of women. 5 WHAT WE LEArnED FroM THE WHIThe findings of the E+P arm (CEE and MPA) of the WHI that were published in 2002 dramatically changed the prescribing practices of physicians in the United States. 6 Before the trial demonstrated adverse cardiovascular disease events and a 26% increased risk of breast cancer in female participants, the number of women for whom E+P was prescribed had been steadily increasing, from 58 million in 1995 to 90 million in 1999.6 From 1999 to 2002, the numbers stabilized; however, within 3 months of publication of the WHI findings, prescriptions for E+P decreased by 63%. Many women stopped HT and some sought out alternative therapies for treatment of symptoms associated with menopause.6 In add...

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“…24: 1796-1806 (2010) exerted a protective effect on bone, increasing BMD and decreasing fracture incidence (Tarakida et al, 2007;Gambacciani et al, 2007). According to the recent review of the WHI investigators (L'Hermite et al, 2008), HRT seems to be a valid option, especially in osteopenic women. During the short-term fracture-healing period (4-10 weeks), the positive effects of estrogen administration may outweigh the negative effects observed during long-term treatment (Stuermer et al, 2008;Kolios et al, , 2010a.…”

Section: Introductionmentioning

confidence: 99%

Absence of positive effect of black cohosh (Cimicifuga racemosa) on fracture healing in osteopenic rodent model

Kolios

Daub

Sehmisch

et al. 2010

Phytotherapy Research

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The healing of predominantly metaphyseal fractures in postmenopausal osteoporosis is delayed and comparatively poor. Due to the potential side effects of HRT, natural alternatives are appealing. The aim of this study was to determine whether Cimicifuga racemosa extract BNO 1055 improves metaphyseal fracture healing in severe osteopenic bone in rats. Thirty-three 12-week-old female rats developed severe osteopenia during 10 weeks after ovariectomy. After metaphyseal tibial-osteotomy and standardized T-plate-osteosynthesis, the healing periods in ovariectomized rats (C), 17-α-estradiol (E) and Cimicifuga racemosa (CR) supplemented diets were assessed for 35 days. Changes in callus morphology were evaluated qualitatively by biomechanical testing and quantitatively in microradiographies and fluorochrome-labeled histological sections. The CR-supplementation slightly improved callus quality and trabecular bone formation. It significantly enhanced the endosteal callus density compared to C group (Cl.Dn.e C: 59.08 ± 21.89, E: 45.95 ± 18.39, CR: 60.85 ± 18.66*), though most of the other morphological parameters examined showed no improvement. The time course of fracture healing did not change due to CR. Estrogen-supplementation enhanced the biomechanical properties of the fracture site. Trabecular bone was improved indicating the physiological endosteal healing process. The CR-supplementation did not exhibit positive effects in severe (senile) osteopenic fracture healing as seen in early (postmenopausal) osteoporosis in rats. Callus formation was slightly improved under CR. Estrogen improved fracture healing in severe osteopenic bone, while the extent of callus formation played a minor role.

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Could transdermal estradiol+progesterone be a safer postmenopausal HRT? A review

Cited by 79 publications

References 220 publications

Physiological Estrogen Replacement Therapy for Puberty Induction in Girls: A Clinical Observational Study

Physiological Estrogen Replacement Therapy for Puberty Induction in Girls: A Clinical Observational Study

Bioidentical Hormone Therapy

Absence of positive effect of black cohosh (Cimicifuga racemosa) on fracture healing in osteopenic rodent model

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