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Cross-reaction of oral contraceptives (OCs) in competitive binding assays of progesterone and estradiol was investigated. The compounds tested were chlormadinone acetate, diethylstilbestrol, dimethisterone, dydrogesterone, ethinyl estradiol, ethynodiol diacetate, megestrol acetate, mestranol, norethynodrel, norethindrone, d-norgestrel, medroxyprogesterone acetate, quinestrol, and quingestanol acetate. Only ethinyl estradiol had a cross-reaction of more than 1% (2%) in the estradiol radioimmunoassay and dydrogesterone (1.4%) and d-norgestrel (4%) were the only compounds that showed a cross-reaction more than 1% in the progesterone competitive protein-binding assay. These results indicate that the steroids tested, in doses currently being used in OCs, will not markedly interfere with the assay of endogenous estradiol and progesterone.
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The results show that the overall effects of Femoston on the serum lipid profile are comparable to those found with oestrogen therapy alone and should reduce the risk of cardiovascular disease in postmenopausal women.
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Main: randomised, prospective, comparative study. Subsidiary: cross-sectional and prospective.
Guidelines recommend using the lowest effective dose of oestrogen for the management of vasomotor symptoms in postmenopausal women. The primary aim of this double-blind, multi-centre, randomised study was to assess the efficacy of oral ultra-low dose continuous combined hormone replacement therapy with 17β-oestradiol and dydrogesterone.
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Menorest is being tested in the prevention of postmenopausal bone loss. A phase II/III clinical program, that includes two double blind, dose-ranging, placebo-controlled, parallel group, 2-year studies, has started in 58 centers in Europe and South Africa. Four-hundred eighty women will be enrolled in the two studies (201 and 305). The objective of the studies is to evaluate the efficacy of Menorest at different doses and regimens, in the prevention of bone loss in early postmenopausal women. In study 201, the treatment regimen is 'cyclic sequential' (24 days of transdermal oestradiol during a 28-day cycle with progestin taken during the last 14 days of oestrogen administration). In study 305 the treatment regimen is "continuous sequential' (28 days of transdermal oestradiol during, a 28-day cycle with progestin taken during the last 14 days of oestrogen administration). The doses studied are 50, 75, 100 micrograms/day in study 201, and 25, 50, 75 micrograms/day in study 305, (the two studies are otherwise identical). All 'active-dose' treated groups receive dydrogesterone 20 mg/day during the last 14 days of Menorest administration and placebo tablets are given to the placebo patch group. The main entry criteria are natural or surgical menopause, (with hormonal confirmation) from 1 to 6 years, with no contra-indication to HRT and with a bone mineral density (BMD) at the lumbar spine with a T-score between 0 and -3. Women with severe vasomotor symptoms are excluded from the studies. The primary efficacy variable is the mean change from baseline, measured with dual energy X-ray absorptiometry (DXA) at 2 years, in the lumbar spine BMD (L1-L4). Whole body and hip BMD are also evaluated. Markers of bone turnover (bone-specific alkaline phosphatase, osteocalcin and CrossLaps) are monitored throughout the study. Blood samples are drawn on the third day of patch application at certain visits in order to monitor oestradiol levels and establish any potential correlation with activity on bone (BMD, bone markers). Besides routine safety analysis, lipid profile and coagulation factors are also monitored. Special attention is drawn to endometrial safety with endometrial aspiration or trans vaginal sonography (TVS) performed before study start, after 1 year and at 2 years of treatment.
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Women with severe PMS confirmed by prospective daily symptom recording.
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The analysis of the results was powered to consider the clinical pregnancy rate, but the live birth rate may be of greater clinical interest. Conclusions relating to the differences between treatments in live birth rate, observed in this study, should therefore be made with caution.
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To investigate the regulation of estrogen-converting enzymes in human ectopic endometrial tissue.
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Dydrogesterone has a molecular structure closely related to that of natural progesterone, but it has enhanced oral availability compared with progesterone. The hormonal profile and the progestational potency of dydrogesterone has been determined in vitro, in vivo and in humans, in combination with estrogens or without. It showed varying affinity for progesterone-binding proteins in uterine tissue in vitro, depending on the species. It exerted a clear progestational response in the rabbit in vivo, although the potency was influenced somewhat by the route of administration. When used in hormone replacement therapy, 10mg dydrogesterone given sequentially provides adequate protection against endometrial hyperplasia in postmenopausal women using 2mg estradiol. Similarly, a dydrogesterone dose of 5mg also protects the endometrium when continuously combined with 1mg estradiol. Dydrogesterone also has beneficial effects in women with amenorrhea/oligomenorrhea, dysfunctional uterine bleeding and irregular cycles. In conclusion, having a similar profile to progesterone but with better oral availability, dydrogesterone has been used successfully to treat disorders related to absolute or relative progesterone deficiency.
Aim of the study was to show different influences of transdermal and oral hormone replacement therapies (conjugated and micronized estrogens) with or without varying dosages of C21-progestogens on serum lipids and lipoproteins.
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Fifteen hysterectomised postmenopausal women were studied before treatment and after 24 weeks taking oestradiol-17 beta alone (2 mg per day), then following a further 6 (oestrogen-alone phase) and 12 (oestrogen plus progestagen phase) weeks with inclusion of dydrogesterone (10 mg per day for days 17-28 of each 28 day cycle). Measurements at each visit included fasting serum lipid and lipoprotein concentrations, insulin sensitivity, secretion and elimination by modelling analysis of intravenous glucose tolerance test glucose, insulin and C-peptide concentrations, body fat distribution by dual-energy X-ray absorptiometry (DXA) and arterial function by carotid artery ultrasound.
HRT improves visual function, promoting a better contrast sensitivity and a higher tear production, but does not modify intraocular pressure.
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In a 12-week randomised controlled study, 48 healthy non-hysterectomised postmenopausal women, aged 41-58 years, received either no treatment (control group; n=16), or daily oral continuous combined treatment with 1 mg micronised 17beta-oestradiol plus 5 mg dydrogesterone (E/D group; n=18) or 0.625 mg conjugated equine oestrogens plus 5 mg medroxyprogesterone acetate (CEE/MPA group; n=14). Fasting blood sampling was performed at baseline and after 12 weeks of follow-up.
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Six synthetic steroids were tested subcutaneously in a new bio-assay for short- and long-lasting progestational activity, using traumatic deciduoma production in immature female rats. As reference standard, a daily subcutaneous dose of 0.25 mg progesterone regularly induced a distinct deciduomagenic effect. A single dose of 12.5 mg of progesterone showed a prolonged activity. Medroxyprogesterone acetate showed a distinct deciduomagenic effect at the 0.05 mg daily s.c. dose level; a distinct prolonged effect was induced with a single s.c. injection of 0.5 mg. 16alpha-Aethylprogesterone induced regularly decidual reaction at the 0.1 mg s.c. dose level, it showed prolonged activity at the 0.25 mg dose level. The daily threshold dose for chlormadinone acetate was 0.25 mg; prolonged activity was shown with 2.5 mg. The daily threshold dose for duphaston is between 0.5 mg and 1.0 mg. A single s.c. dose of as much as 20.0 mg of 17alpha- hydroxyprogesterone caproate did not have a deciduomagenic effect.
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To assess the effects of hormone replacement therapy (HRT) on visual function after menopause.
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Progestogens appear to have a dual effect on the cell cycle in breast cells and breast cancer cells. There is initially stimulation of mitotic activity. However, continuous application leads to cell apoptosis. This depends on type, dose and length of progestogen application in relation to estrogen action. In benign breast disease the use of progestogens results not only in reduction of mastodynia, but also a reduction in breast gland size and disappearance of nodularity proven by clinical examination and follow-up including breast ultrasound.
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To investigate the association between estradiol therapy and incidence of breast cancer, taking into consideration of different types of combined progestogen, the duration of exposure and the type of regimen.
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The decrease in endometrial thickness in phase 0 suggests a protective effect of our cyclic sequential regimen on the endometrium. Dydrogesterone does not interfere markedly with the vasodilatory effect of estrogen on uterine arteries.
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Most menopausal endometria were normal regardless of the regimens of HRT. Endometrial hyperplasia was only found in two cases (both in group A). The S-G2-M fractions of the endometrial cells in all three menopausal groups showed no statistically significant difference. It appeared that S-G2-M fractions increased from normal postmenopausal to normal premenopausal endometria to postmenopausal hyperplasia to premenopausal hyperplasia. The S-G2-M fractions of the normal menopausal endometrial cells were lower than those of the premenopausal controls either in normal or in hyperplastic categories.
To compare the efficacy of oral dydrogesterone with that of micronized vaginal P gel and micronized P capsule for luteal supplementation.
Compared with conservative management, dydrogesterone had beneficial effects on maintaining pregnancy in women with threatened miscarriage.
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Menopause can cause cognitive decline. Hormone Replacement Therapy (HRT) is the most effective treatment for the climacteric symptoms. However, its cognitive effect has not been well clarified, especially for the progestin component. The study investigated the effects of dydrogesterone (DG) on spatial learning and memory of the ovariectomized (OVX) rat models and the impact of aging on its cognitive effects. Eighty female Sprague-Dawley rats were included in the experiment. They belonged to two cohorts, the adult (7 months) and the aged (18 months). Each cohort was divided into five groups: Sham, OVX, OVX+E2 (OVX+17β-estrogen), OVX+E2/DG and OVX+DG. The replacement therapy lasted for 20 weeks. Two classical behavioral tests were performed: open field test (OFT) and the Morris water maze (MWM). The breast morphology and uterine weight were obtained to assess the safety and complication of dydrogesterone. In MWM, the OVX group displayed prolonged latency and less target quadrant time than the other groups. Across 5 days' testing, all the adult groups receiving hormone therapy, except the OVX+DG group, performed better than the OVX group (P<0.001); but there was no significant difference among the aged groups. The uterus weight/body weight ratio of OVX+E2/DG group was lower than the sham and OVX+E2 group. The mammary glands of OVX+E2/DG group displayed normal structure or mild hyperplasia. The results suggested that DG-alone treatment had no significant benefit for the OVX rats of both adult and aged groups on the behavioral tests. DG combined with E2 could ameliorate cognition in adult rats with uterus protection and without breast harm. The cognitive-improve effects were more remarkable for the adult rats than the aged ones. The findings support the potential clinical application of dydrogesterone combined with estrogen in preventing cognitive decline, especially for the early iatrogenic menopausal women.