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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).
The menopause
Published in Michael J. O’Dowd, The History of Medications for Women, 2020
Reports from the early 1970s were supported by the findings of the Framingham Study of Kannel and associates (1976) who reported that post-menopausal women had an increased risk of coronary heart disease in comparison to pre-menopausal women of the same age. Ross and coworkers (1981) discovered that the administration of conjugated estrogens to postmenopausal women over a period of five years reduced the relative mortality rate from ischemic heart disease.
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]
A multicenter, randomized, open, controlled trial to evaluate the efficacy of Honglilai Vaginal Cream and Premarin Vaginal Cream for Genitourinary Syndrome of Menopause in different subgroups of Chinese postmenopausal women
Published in Gynecological Endocrinology, 2022
Mukun Yang, Shouqing Lin, Shurong Zheng, Aijun Sun, Meilu Bian, Shilan Li, Jianli Liu, Lina Hu, Ning Hui, Jing Zhong, Hongchun Hou, Tianfu Yue, Xiaoli Gao, Wenpei Bai
The general health of postmenopausal women is a public issue of worldwide concern [1,2]. Genitourinary Syndrome of Menopause (GSM) is a common affliction involving changes in not only the genital area but also the urinary tract that affects up to 50% of postmenopausal women [3–5]. Its symptoms include vaginal itching, burning, dryness, irritation, and dyspareunia, which affect interpersonal relationships, even urinary and sexual function [5–7]. Studies have shown that GSM is associated with reduced vaginal secretions, vulvovaginal atrophy, and decreased glycogen production by vaginal epithelial cells after menopause, which possibly renders the vagina more susceptible to infections [8]. So far, the first-line treatment of GSM is low-dose, minimally absorbed local estrogen therapy [9–11], which was recommended by the North American Menopause Society (NAMS) and the International Menopause Society (IMS) [12–14]. Premarin vaginal cream is a commonly used estrogenic cream for the treatment of GSM. Honglilai Vaginal Cream is a type of Conjugated estrogens vaginal cream, which has been extracted from pregnant mares’ urine. Honglilai Vaginal Cream has been widely used in China as a local product and its effect has been conformed in several domestic studies. The present study aimed to evaluate the efficacy of Honglilai Vaginal Cream on GSM and screen the targeting patients in different age and menopausal year subgroups in comparison to Premarin vaginal cream.