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Postmenopause
Published in Carolyn Torkelson, Catherine Marienau, Beyond Menopause, 2023
Carolyn Torkelson, Catherine Marienau
Alternative opinions on menopause and hormone therapy started to circulate during the 1980s and 1990s. Michael Murray, ND, a naturopath, wrote Menopause to promote the natural approach to alleviate menopause symptoms.3 Dr. Jonathan Wright was one of the first physicians to write individualized prescriptions for hormone therapy using compounding pharmacies instead of FDA-approved, commercially available conjugated estrogens. In Natural Hormone Replacement for Women Over 45, Dr. Wright presented a template for how to prescribe compounded hormone therapy, which he suggested was safer than conjugated estrogens.4 In another important book, What Your Doctor May Not Tell You About Menopause, Dr. John Lee advocated using a combination of natural estrogen and progesterone for hormone balance and disease prevention as opposed to using synthetic estrogen therapy.5
Statistical Methods for Assessment of Complex Generic Drugs
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Naturally-sourced conjugated estrogens tablet is another representative instance of this category. Naturally-sourced conjugated estrogens is a complex mixture derived from pregnant mares' urine. As indicated in the PSG of naturally-sourced conjugated estrogens, the sameness of API can be established based on comparative physicochemical characterizations, and following tests should be conducted (US FDA, 2014b): (i) identification test for steroidal components; (ii) the USP quantification test for ten steroidal components; (iii) control of major non-USP steroidal components; (iv) control of additional steroidal components in the test API batches; (v) total steroidal components content test; and (vi) non-steroidal components in the test API batches. The sameness of API could be established if corresponding qualitative and quantitative criteria are met. After that, Four in vivo BE studies for different strengths, as well as fed and fasting state, should be conducted to establish BE between generic products and innovative products.
Monographs of Topical Drugs that Have Caused Contact Allergy/Allergic Contact Dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
Estrogens, conjugated, is a pharmaceutical preparation containing a mixture of water-soluble, conjugated estrogens derived wholly or in part from urine of pregnant mares or synthetically from estrone and equilin. It contains a sodium-salt mixture of estrone sulfate (52-62%) and equilin sulfate (22-30%) with a total of the two between 80 and 88 per cent. Other concomitant conjugates include 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. The product is indicated for use as treatment of vasomotor symptoms or vulvar and vaginal atrophy due to menopause, hypoestrogenism due to hypogonadism, castration or primary ovarian failure, as palliative treatment of breast cancer with metastatic disease, as palliative treatment of androgen-dependent carcinoma of the prostate, and as preventive therapy for postmenopausal osteoporosis (1).
A focused report on progestogen hypersensitivity
Published in Expert Review of Clinical Immunology, 2023
Diti H. Patel, Lauren M. Fine, Jonathan A. Bernstein
A variety of other hormonal treatments targeting the hypothalamus-pituitary-gonadal axis have also been used. However, these agents may interfere with the patient’s fertility and should be used only after shared decision-making with the patient and their gynecologist. GnRH agonists, such as leuprolide acetate, administered daily intranasally or IM every 3 months may be used for refractory cases [9,23]. Other therapies such as danazol (alkylated steroids), tamoxifen (SERM), or spironolactone have been used but have shown variable results [23,45,51]. Furthermore, alkylated steroids have side effects that may limit their chronic use, including the growth of abnormal facial or body hair, hepatic dysfunction, and mood disorders [37]. Some reports have advocated treatment with high dose conjugated estrogens [18,52]. However, elevated amounts of unopposed estrogen increase the risk of hormone sensitive endometrial and breast cancers.
The influence of estro-progestin therapy on neurohormonal activity in functional hypothalamic amenorrhea
Published in Gynecological Endocrinology, 2022
Anna Szeliga, Agnieszka Podfigurna, Gregory Bala, Blazej Meczekalski
After treatment completion, patients in the FHA group were found to have an overall increase in serum insulin concentration and a statistically significant increase in HOMA-IR. These results can be confirmed in the literature, where insulin resistance was observed as a result of HRT. [23, 24] Nevertheless, conclusive data on the effect of HRT on insulin concentration is incomplete and at best contradictory. Studies have shown both no effect of HRT on insulin resistance [25], as well as statistically significant reductions in insulin concentration and HOMA-IR after using HRT. [26] These inconsistent observations may be the product of differences in age of the study populations or even differences in the hormonal preparations used. In studies where conjugated estrogens were used at a dose of 0.625 mg with the addition of medroxyprogesterone acetate (2.5 mg), insulin resistance was more readily observed. On the other hand, when 17-β-estradiol was used in a dose of 1 mg in combination with norethisterone acetate at a dose of 0.5 mg there was no statistically significant difference in HOMA-IR, but when the same estrogen was used in combination with 2 mg of drospirenone, a statistically significant decrease in insulin resistance was observed. [23–26]
Primary choice of estrogen and progestogen as components for HRT: a clinical pharmacological view
Published in Climacteric, 2022
CEEs are primarily produced by extraction from the urine of pregnant mares (which may also raise the question of animal welfare), where the lowest layer contains 50–65% sodium estrone sulfate, the middle layer contains up to 30% different (not all specified) equine (i.e. not human) estrogens and the upper layer contains the second important content of the mixture, 20–35% sodium equilin sulfate. The main components of CEE, as well as of so-called ‘conjugated estrogens’ (also from horses or in part synthetically produced), are sodium estrone sulfate and sodium equilin sulfate. These components can vary between 52.5–61.5% and 22.5–30.5%, respectively, according to the United States Pharmacopeia 27 (USP 27) defined in Martindale [11], one of the main sources for clinical pharmacologists regarding the description of drug properties. The total of the combined two should be between 79.5 and 88% [11]. For standardization, the registration offices only ask in terms of these two estrogens. In addition, these mixtures should contain 13.5–19.5% 17-α-dihydro-equilin, 2.5–9.5% 17-α-estradiol and 0.5–4.0% of 17β-dihydro-equilin, all as sulfates [11].