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  • 1
    Electronic Resource
    Electronic Resource
    A dose-ranging study of the use of cyclical dydrogesterone with continuous 17β oestradiol (1995)
    Oxford, UK : Blackwell Publishing Ltd
    BJOG 102 (1995), S. 0 
    Details
    ISSN: 1471-0528
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Objective To establish the lowest dose of cyclical dydrogesterone that protects against endometrial hyperplasia induced by continuous 2 mg 17β oestradiol, and to study the dose effect on vaginal bleeding and side effects.Design Double-blind, prospectively randomised dose-ranging study.Setting Menopause clinics in the UK and The Netherlands.Subjects Three hundred and seventy-one postmenopausal women with intact uteri, aged 40 to 60.Interventions Administration of six 28-day treatment cycles of continuous daily micronised 178 oestradiol with a randomly allocated dose of 5 to 20 mg of dydrogesterone added for the last 14 days of each.Main outcome measures Histological assessment of adequate progestational endometrial response, bleeding patterns and adverse effects.Results The study was completed by 320 subjects (86 %). Endometrial transformation occurred in over 94 % of those talung 5 mg of dydrogesterone, and in over 97 % of those on hgher doses, without significant differences between the 10, 15 and 20 mg groups. Acceptable bleeding patterns were found at all doses, with the incidence of withdrawal bleeding rising with increasing dose. The day of onset of bleeding was predictable from cycle to cycle, and occurred later in the 20 mg group than in the others. The incidence of noncyclic bleeding was about 6 % at all doses. Withdrawal occurred in 3-3% due to unacceptable bleeding and in 5-4% due to side effects. There was no relation with dose.Conclusions A dydrogesterone-17p oestradiol combination hormone replacement therapy confers endometrial protection with an acceptable bleeding pattern and few side effects. At least 10 mg of dydrogesterone for 14 days is required for acceptable endometrial protection.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1471-0528.1995.tb09102.x
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  • 2
    Electronic Resource
    Electronic Resource
    Endometrial, physical and psychological effects of postmenopausal oestrogen therapy with added dydrogesterone (1990)
    Oxford, UK : Blackwell Publishing Ltd
    BJOG 97 (1990), S. 0 
    Details
    ISSN: 1471-0528
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Summary. Sixteen postmenopausal women receiving conjugated equine oestrogens 1.25 mg/day. continuously, were randomly allocated to add dydrogesterone 20 mg/day for 12 days each calendar month for 3 months and then 10 mg/day in an identical fashion for a further 3 months, or to receive the dydrogesterone doses in reverse sequence. The effects of the two dydrogesterone doses on endometrial histology, vaginal bleeding, and the symptomatic and psychological status were compared. Endometrial samples were obtained around day 10 of progestogen addition. Dydrogesterone, 20 mg, induced uniform, late secretory transformation in all samples; with 10 mg one sample showed mixed early and late secretory features and another demonstrated late secretory changes associated with atypical hyperplasia. Both dydrogesterone doses induced an acceptable withdrawal bleed; most bleeding episodes were ‘spotting’ or normal in amount, and heavy bleeding was reported infrequently. There was one episode of breakthrough bleeding. There were no differences in bleeding patterns between the two dose regimens. Anxiety, and the physical and psychological status were significantly improved after 3 months of therapy. Significant benefits on depression were observed less clearly. There were no differences between the two dydrogesterone doses on anxiety, depression and the physical and psychological status, and, overall, the addition of the progestogen did not antagonize oestrogen benefits.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1471-0528.1990.tb02497.x
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    Effect on plasma lipids and lipoproteins of postmenopausal oestrogen therapy with added dydrogesterone (1990)
    Oxford, UK : Blackwell Publishing Ltd
    BJOG 97 (1990), S. 0 
    Details
    ISSN: 1471-0528
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Summary. In a prospective, randomized, cross-over study, 14 postmenopausal women completed 9 months of treatment with conjugated equine oestrogens, 1.25 mg daily. Seven women added dydrogesterone 20 mg daily for 12 days during months 2, 3 and 4, and then 10 mg daily for an identical time in months 5,6 and 7. The other seven women added the two dydrogesterone doses in reverse sequence. No dydrogesterone was taken during months 8 and 9. Lipids and lipoproteins were measured before treatment and at the end of months 4, 7 and 9. Lipids were also estimated in an untreated (reference) group of eight postmenopausal women on two occasions 6 months apart; these showed significant changes in HDL2- and HDL3-cholesterol. In the treatment group, HDL-cholesterol and apolipoprotein (apo) Al were significantly higher and LDL-cholesterol and apo B were significantly lower at months 4, 7 and 9 compared with baseline values. Triglyceride levels were increased significantly over baseline values, but remained within the normal range. No significant differences between the two dydrogesterone doses were observed on any lipid and lipoprotein fraction, nor were there any differences between the oestrogen-only and oestrogen/dydrogesterone treatment phases. Dydrogesterone appears to cause little, if any, lipid and lipoprotein changes and assessment in a larger population of postmenopausal women is warranted.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1471-0528.1990.tb02496.x
    Library Location Call Number Volume/Issue/Year Availability
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    Paper (German National Licenses)
    Fulltext
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