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Mats Hammar - One of the best experts on this subject based on the ideXlab platform.
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Low dose transdermal estradiol/Norethisterone Acetate treatment over 2 years does not cause endometrial proliferation in postmenopausal women.
Menopause, 2002Co-Authors: Jan Brynhildsen, Mats HammarAbstract:Objective: We investigated the effects of 2-year transdermal continuous combined estradiol (0.025 mg/day) and Norethisterone Acetate (0.125 mg/day) (Estragest TTS) on bleeding and on the endometrium. Design: This double-blind, randomized, multicenter, parallel, 1-year trial enrolled 266 healthy women at least 2 years past menopause with intact uteri. Patients received a transdermal patch delivering either 0.025 mg estradiol and 0.125 mg Norethisterone Acetate daily or placebo. Of the 266 women initially included, 135 (96 Estragest TTS, 39 placebo) completed a second year open follow-up, where all women had the estradiol/Norethisterone patch. Endometrial biopsies were performed at weeks 0, 48 (n = 171), and 96 (n =109). Effects on endometrial morphology and uterine bleeding were studied. Results: The overall incidence of endometrial hyperplasia after treatment with the estradiol/Norethisterone Acetate patch for one year was 0.8% with only one case of atypical hyperplasia. There were no clinically significant changes in endometrial thickness in either treatment group. The proportion of bleed-free patients with the estradiol/Norethisterone Acetate transdermal system increased from 55% in cycles 1-3 to 83% in cycles 10-12. By the 12th cycle, 92% of patients receiving estradiol/Norethisterone Acetate patches were bleed-free. No additional hyperplasia was seen during the second year follow-up. Conclusions: A continuous combined transdermal patch delivering 0.025 mg estradiol/day and 0.125 mg Norethisterone Acetate/day provided good endometrial protection. The dose maintained a consistently high rate of amenorrhea in postmenopausal women.
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low dose transdermal estradiol Norethisterone Acetate treatment over 2 years does not cause endometrial proliferation in postmenopausal women
Menopause, 2002Co-Authors: Jan Brynhildsen, Mats HammarAbstract:Objective: We investigated the effects of 2-year transdermal continuous combined estradiol (0.025 mg/day) and Norethisterone Acetate (0.125 mg/day) (Estragest TTS) on bleeding and on the endometrium. Design: This double-blind, randomized, multicenter, parallel, 1-year trial enrolled 266 healthy women at least 2 years past menopause with intact uteri. Patients received a transdermal patch delivering either 0.025 mg estradiol and 0.125 mg Norethisterone Acetate daily or placebo. Of the 266 women initially included, 135 (96 Estragest TTS, 39 placebo) completed a second year open follow-up, where all women had the estradiol/Norethisterone patch. Endometrial biopsies were performed at weeks 0, 48 (n = 171), and 96 (n =109). Effects on endometrial morphology and uterine bleeding were studied. Results: The overall incidence of endometrial hyperplasia after treatment with the estradiol/Norethisterone Acetate patch for one year was 0.8% with only one case of atypical hyperplasia. There were no clinically significant changes in endometrial thickness in either treatment group. The proportion of bleed-free patients with the estradiol/Norethisterone Acetate transdermal system increased from 55% in cycles 1-3 to 83% in cycles 10-12. By the 12th cycle, 92% of patients receiving estradiol/Norethisterone Acetate patches were bleed-free. No additional hyperplasia was seen during the second year follow-up. Conclusions: A continuous combined transdermal patch delivering 0.025 mg estradiol/day and 0.125 mg Norethisterone Acetate/day provided good endometrial protection. The dose maintained a consistently high rate of amenorrhea in postmenopausal women.
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Plasma lipid and lipoprotein effects of transdermal administration of estradiol and estradiol/Norethisterone Acetate.
European Journal of Obstetrics & Gynecology and Reproductive Biology, 1992Co-Authors: Richard Lindgren, Mats Hammar, Göran Berg, Ulf Larsson-cohn, Anders G. OlssonAbstract:Abstract To evaluate the effect of transdermal sequential treatment with estradiol and estradiol/ Norethisterone Acetate on lipoprotein metabolism, 25 postmenopausal women received treatment for 12 cycles of 4 weeks each (2 weeks estradiol 50 μg/day and 2 weeks a combined patch delivering Norethisterone Acetate 0.25 mg/day and estradiol 50 μg/day). Blood samples for lipoprotein analyses were drawn before treatment and in estrogen and combined phases in cycles 3 and 12. Plasma total cholesterol, low (LDL) and high (HDL) density lipoprotein were all significantly reduced in both estrogen and combined phases. Eighteen of the women continued the treatment for 36 cycles. In this group the HDL-cholesterol had returned to baseline values in combined phase in cycle 24. Plasma cholesterol and LDL-cholesterol values remained significantly reduced throughout the whole study compared to the pre-trial values. The present study by transdermal sequential hormonal treatment results in a lipid and lipoprotein pattern with reduced total cholesterol and LDL cholesterol in postmenopausal women.
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plasma lipid and lipoprotein effects of transdermal administration of estradiol and estradiol Norethisterone Acetate
European Journal of Obstetrics & Gynecology and Reproductive Biology, 1992Co-Authors: Richard Lindgren, Mats Hammar, Göran Berg, Ulf Larssoncohn, Anders G. OlssonAbstract:Abstract To evaluate the effect of transdermal sequential treatment with estradiol and estradiol/ Norethisterone Acetate on lipoprotein metabolism, 25 postmenopausal women received treatment for 12 cycles of 4 weeks each (2 weeks estradiol 50 μg/day and 2 weeks a combined patch delivering Norethisterone Acetate 0.25 mg/day and estradiol 50 μg/day). Blood samples for lipoprotein analyses were drawn before treatment and in estrogen and combined phases in cycles 3 and 12. Plasma total cholesterol, low (LDL) and high (HDL) density lipoprotein were all significantly reduced in both estrogen and combined phases. Eighteen of the women continued the treatment for 36 cycles. In this group the HDL-cholesterol had returned to baseline values in combined phase in cycle 24. Plasma cholesterol and LDL-cholesterol values remained significantly reduced throughout the whole study compared to the pre-trial values. The present study by transdermal sequential hormonal treatment results in a lipid and lipoprotein pattern with reduced total cholesterol and LDL cholesterol in postmenopausal women.
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Endometrial effects of transdermal estradiol/Norethisterone Acetate.
Maturitas, 1992Co-Authors: Richard Lindgren, Björn Risberg, Mats Hammar, Göran Berg, J. Pryse-daviesAbstract:Abstract The efficacy of transdermal Norethisterone Acetate in sequence with transdermal estradiol has been investigated in a multicenter study of 136 post-menopausal women to determine the incidence of endometrial hyperplasia, the effects on the vaginal cytology and the control of bleeding. Treatment consisted of 12 cycles of 4 weeks each (2 weeks estradiol 50 μg/day followed by 2 weeks of a new combined patch delivering Norethisterone Acetate 0.25 mg/day and estradiol 50 μg/day). Endometrial histology was assessed by two pathologists. Of the 136 pre-treatment biopsies 89% provided no material, an inadequate sample or an inactive (atrophic or non-secretory) endometrium. Of the post-treatment biopsies from 110 women who completed the study: 65% showed secretory, 3% proliferative and 24% inadequate material or inactive endometrium. Hyperplasia was found in two biopsies (2%); in one of these focal atypical hyperplasia was agreed by both pathologists, in another a hyperplastic endometrial polyp was diagnosed by one pathologist. The bleeding was regular in 80% of the 1195 cycles and irregular in 11%. No bleeding occured in 9% of the cycles. Vaginal cytology showed a significant shift towards increased maturation during treatment.
M Hammar - One of the best experts on this subject based on the ideXlab platform.
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effect on sexual life a comparison between tibolone and a continous estradiol Norethisterone Acetate regimen
Maturitas, 1996Co-Authors: J Nathorstboos, M HammarAbstract:Abstract Objectives: to compare the effects of tibolone 2.5 mg (Livial®) with those of 17β-estradiol 2 mg plus Norethisterone Acetate 1 mg (Kliogest®) on sexual life. Methods: in a 48 week, double blind, multicenter study, 437 postmenopausal women were randomised to treatment with either tibolone or 17β-estradiol 2 mg plus Norethisterone Acetate. Treatment groups were compared with respect to different aspects of sexual life with a questionnaire covering sexual experience and responsiveness during the last 30 days. Results: a total of 315 subjects completed 48 weeks treatment. In the E2 NETA group an improvement after 48 weeks compared to baseline was observed in five out of seven items assessing sexual life. In the tibolone group an improvement regarding all seven items assessing sexual life was seen. When tibolone was compared to E2 NETA significantly higher scores were found for the items assessing ‘frequency’, ‘satisfaction’ and ‘enjoyment’. Conclusions: this study indicate that tibolone and E2 NETA -which both have an androgenic profile-affect several aspects of sexual life positively. The difference with respect to satisfaction with sexual enjoyment and frequency could be of clinical importance.
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Effect on sexual life — a comparison between tibolone and a continous estradiol-Norethisterone Acetate regimen
Maturitas, 1996Co-Authors: J Nathorst-böös, M HammarAbstract:Abstract Objectives: to compare the effects of tibolone 2.5 mg (Livial®) with those of 17β-estradiol 2 mg plus Norethisterone Acetate 1 mg (Kliogest®) on sexual life. Methods: in a 48 week, double blind, multicenter study, 437 postmenopausal women were randomised to treatment with either tibolone or 17β-estradiol 2 mg plus Norethisterone Acetate. Treatment groups were compared with respect to different aspects of sexual life with a questionnaire covering sexual experience and responsiveness during the last 30 days. Results: a total of 315 subjects completed 48 weeks treatment. In the E2 NETA group an improvement after 48 weeks compared to baseline was observed in five out of seven items assessing sexual life. In the tibolone group an improvement regarding all seven items assessing sexual life was seen. When tibolone was compared to E2 NETA significantly higher scores were found for the items assessing ‘frequency’, ‘satisfaction’ and ‘enjoyment’. Conclusions: this study indicate that tibolone and E2 NETA -which both have an androgenic profile-affect several aspects of sexual life positively. The difference with respect to satisfaction with sexual enjoyment and frequency could be of clinical importance.
E Lang - One of the best experts on this subject based on the ideXlab platform.
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Ultra-low-dose continuous combined estradiol and Norethisterone Acetate: improved bleeding profile in postmenopausal women
Climacteric, 2008Co-Authors: D. W. Sturdee, David F Archer, V. Rakov, E LangAbstract:Objective To evaluate the effect of two ultra-low-dose hormone treatments containing estradiol (E2) 0.5 mg and Norethisterone Acetate (NETA) 0.1 or 0.25 mg on the endometrium and bleeding.Methods A prospective, randomized, placebo-controlled trial of 6 months. Local Ethics Committee approval and informed consent were obtained prior to initiation and enrolment. Out of 577 postmenopausal women randomized, 575 took E2/NETA 0.1 (n = 194), or E2/NETA 0.25 (n = 181) or placebo (n = 200). Endometrial bleeding was monitored by daily diary cards and endometrial thickness by transvaginal ultrasound at baseline and on completion. An endometrial biopsy was obtained when indicated clinically.Results In months 1–6, the amenorrhea rates with E2/NETA 0.1 were 89%, 89%, 86%, 85%, 89% and 89%, respectively and the no-bleeding rates were correspondingly high: 95%, 94%, 93%, 90%, 95% and 95%. The amenorrhea and spotting-only rates were similar with both ultra-low-dose combinations. The withdrawal rates due to bleeding were v...
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ultra low dose estradiol and Norethisterone Acetate effective menopausal symptom relief
Climacteric, 2007Co-Authors: N Panay, Olavi Ylikorkala, David F Archer, R Gut, E LangAbstract:Objective To evaluate the efficacy of two ultra-low-dose 17b-estradiol plus Norethisterone Acetate (NETA) treatment regimens for relieving menopausal symptoms. Design A total of 577 postmenopausal women were enrolled, in three treatment groups in a double-blind, randomized, placebo-controlled study of 0.5 mg 17b-estradiol þ 0.1 mg NETA or 0.5 mg 17b-estradiol þ 0.25 mg NETA or placebo. Participants returned at weeks 4, 8, 12 and 24 for climacteric complaint evaluation based on a daily diary vasomotor symptom record. Patients were assessed by the Greene Climacteric Scale and urogenital symptoms were also evaluated. Results Treatment with ultra-low-dose 0.5 mg 17b-estradiol þ 0.1 mg NETA (0.1 Group) or 0.5 mg 17b-estradiol þ 0.25 mg NETA (0.25 Group) effectively reduced the severity and number of hot flushes within the initial weeks of therapy. Compared to placebo, a rapid, statistically significant decrease in the frequency and severity of hot flushes was achieved by week 3, followed by further improvement which continued throughout the study. There were no statistically significant differences between the active treatment arms. Conclusions The data show that both ultra-low-dose regimens are effective in reducing the severity and number of hot flushes compared to placebo, with good safety profiles.
J Nathorstboos - One of the best experts on this subject based on the ideXlab platform.
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effect on sexual life a comparison between tibolone and a continous estradiol Norethisterone Acetate regimen
Maturitas, 1996Co-Authors: J Nathorstboos, M HammarAbstract:Abstract Objectives: to compare the effects of tibolone 2.5 mg (Livial®) with those of 17β-estradiol 2 mg plus Norethisterone Acetate 1 mg (Kliogest®) on sexual life. Methods: in a 48 week, double blind, multicenter study, 437 postmenopausal women were randomised to treatment with either tibolone or 17β-estradiol 2 mg plus Norethisterone Acetate. Treatment groups were compared with respect to different aspects of sexual life with a questionnaire covering sexual experience and responsiveness during the last 30 days. Results: a total of 315 subjects completed 48 weeks treatment. In the E2 NETA group an improvement after 48 weeks compared to baseline was observed in five out of seven items assessing sexual life. In the tibolone group an improvement regarding all seven items assessing sexual life was seen. When tibolone was compared to E2 NETA significantly higher scores were found for the items assessing ‘frequency’, ‘satisfaction’ and ‘enjoyment’. Conclusions: this study indicate that tibolone and E2 NETA -which both have an androgenic profile-affect several aspects of sexual life positively. The difference with respect to satisfaction with sexual enjoyment and frequency could be of clinical importance.
Malcolm Whitehead - One of the best experts on this subject based on the ideXlab platform.
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effects of tibolone or continuous combined oestradiol Norethisterone Acetate on glucose and insulin metabolism
Clinical Endocrinology, 2013Co-Authors: Nik Manassiev, Malcolm Whitehead, Ian F. Godsland, Anthony J. Proudler, John C. StevensonAbstract:SummaryObjective To determine the effects of tibolone or oestradiol (E2)/Norethisterone Acetate (NETA) hormone replacement therapy on glucose and insulin metabolism in postmenopausal women. Design Single-centre double-blind placebo-controlled randomized clinical trial. Subjects/Methods We randomized 105 healthy postmenopausal women to tibolone 2·5 mg daily, continuous combined oral E2 2 mg/NETA 1 mg daily or placebo over a 2-year study. We performed intravenous glucose tolerance tests (IVGTT) with measurements of plasma glucose, insulin and C-peptide concentrations and the IVGTT glucose elimination rate, k. Mathematical modelling was performed to determine measures of insulin sensitivity, Si, pancreatic insulin secretion and hepatic and plasma insulin elimination. Results Tibolone decreased Si to 53–63% and k to 72–79% of baseline values but increased IVGTT phase 2 C-peptide concentrations 1·6–1·8-fold and pancreatic insulin secretion 2·2–2·4-fold, so overall IVGTT glucose concentrations were unaffected. Similar, but for k, significantly smaller changes in insulin and C-peptide secretion were seen with E2/NETA, also with no effect on overall IVGTT glucose concentrations. Conclusions Tibolone reduces insulin sensitivity. Healthy postmenopausal women seem able to compensate for this and maintain normal postload glucose concentrations, but it may not be advisable to prescribe tibolone to women with, or at increased risk for, diabetes.
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Effects of tibolone or continuous combined oestradiol/Norethisterone Acetate on glucose and insulin metabolism.
Clinical Endocrinology, 2013Co-Authors: Nik Manassiev, Malcolm Whitehead, Ian F. Godsland, Anthony J. Proudler, John C. StevensonAbstract:SummaryObjective To determine the effects of tibolone or oestradiol (E2)/Norethisterone Acetate (NETA) hormone replacement therapy on glucose and insulin metabolism in postmenopausal women. Design Single-centre double-blind placebo-controlled randomized clinical trial. Subjects/Methods We randomized 105 healthy postmenopausal women to tibolone 2·5 mg daily, continuous combined oral E2 2 mg/NETA 1 mg daily or placebo over a 2-year study. We performed intravenous glucose tolerance tests (IVGTT) with measurements of plasma glucose, insulin and C-peptide concentrations and the IVGTT glucose elimination rate, k. Mathematical modelling was performed to determine measures of insulin sensitivity, Si, pancreatic insulin secretion and hepatic and plasma insulin elimination. Results Tibolone decreased Si to 53–63% and k to 72–79% of baseline values but increased IVGTT phase 2 C-peptide concentrations 1·6–1·8-fold and pancreatic insulin secretion 2·2–2·4-fold, so overall IVGTT glucose concentrations were unaffected. Similar, but for k, significantly smaller changes in insulin and C-peptide secretion were seen with E2/NETA, also with no effect on overall IVGTT glucose concentrations. Conclusions Tibolone reduces insulin sensitivity. Healthy postmenopausal women seem able to compensate for this and maintain normal postload glucose concentrations, but it may not be advisable to prescribe tibolone to women with, or at increased risk for, diabetes.
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Does low-dose, transdermal, Norethisterone Acetate reliably cause endometrial transformation in postmenopausal oestrogen-users?
Maturitas, 2005Co-Authors: D. Fraser, Malcolm Whitehead, Lotte Schenkel, J. Pryse-daviesAbstract:Abstract In a prospective study, the symptomatic, psychological and endometrial effects of a combined oestradiol/progestogen transdermal therapeutic system which delivers a low daily dose of Norethisterone Acetate have been investigated in 18 postmenopausal women. Treatment was given in 28 day cycles. Patients received transdermal oestradiol 50 μg/day continuously and transdermal Norethisterone Acetate, 0.1–0.15 mg/day, was added for 14 days. Treatment was given for between 5 and 7 cycles. One patient discontinued therapy because of a skin reaction. Low dose, transdermal Norethisterone Acetate caused few adverse symptomatic or psychological side-effects and appeared well tolerated. Fourteen endometrial samples were obtained during the combined (Norethisterone Acetate/oestradiol) phase of the 5th, 6th or 7th treatment cycle. None showed hyperplastic or malignant change but proliferative endometrium, indicative of an inadequate progestational stimulus, was observed in 4 biopsy samples. Three of these patients had reported breakthrough bleeding during therapy. For these reasons, we regard this dose of transdermal Norethisterone Acetate as inadequate in combination with transdermal oestradiol 50 μg/day for routine use in postmenopausal oestrogen users.
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A randomised comparison of the effects of oral versus transdermal 17β‐oestradiol, each combined with sequential oral Norethisterone Acetate, on serum lipoprotein levels
British Journal of Obstetrics and Gynaecology, 1999Co-Authors: Chris Spencer, Malcolm Whitehead, David Crook, D Ross, Alison J. Cooper, J. C. StevensonAbstract:Objective To investigate the effects of oral versus, transdermal 17β-oestradiol, given in both cases with sequential addition of oral Norethisterone Acetate, on serum lipid and lipoprotein levels in postmenopausal women. Design Open, randomised, parallel groups study. Setting University Clinical Research Group. Population Sixty-four postmenopausal women with climacteric complaints who were otherwise healthy were screened. Of these, 58 fulfilled the entry criteria. Methods Fifty-eight postmenopausal women were randomised to receive either oral 17β-oestradiol/oestriol (Trisequens) or transdermal 17β-oestradiol (Estrapak) together with cyclical addition of Norethisterone Acetate for 48 weeks. Main outcome measures Serum levels of total cholesterol, triglycerides, high density lipoproteins (HDL), low density lipoproteins (LDL), very low density lipoproteins (VLDL), apolipoproteins, and lipoprotein(a) at baseline, and after 46 weeks (oestrogen-alone phase), and 48 weeks (oestrogen-progestogen phase) of treatment. Results Oral oestradiol therapy did not affect serum total cholesterol levels during the oestrogen-alone phase, but during the combined phase there was a 5% fall (P < 0.05) due to a 7% decrease in LDL cholesterol levels (P < 0.01). Oral therapy also increased serum triglyceride levels by 9.4% during the oestrogen-alone phase (P < 0.05). During the combined phase of transdermal therapy, there was a 19% fall in serum triglyceride levels (P < 0.05) and a 6%, fall in HDL levels (P < 0.05). Oral oestradiol reduced lipoprotein(a) levels by 31% during the oestrogen-alone phase and by 37% with Norethisterone Acetate addition (P < 0.05). Transdermal therapy had no significant effect on lipoprotein(a). Conclusions Other than a minor fall in HDL, in women receiving transdermal 17β-oestradiol, co-administration of oral progestogen in general improved, rather than worsened, this serum lipoprotein profile.
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a randomised comparison of the effects of oral versus transdermal 17β oestradiol each combined with sequential oral Norethisterone Acetate on serum lipoprotein levels
British Journal of Obstetrics and Gynaecology, 1999Co-Authors: Chris Spencer, Malcolm Whitehead, David Crook, D Ross, Alison J. Cooper, J. C. StevensonAbstract:Objective To investigate the effects of oral versus, transdermal 17β-oestradiol, given in both cases with sequential addition of oral Norethisterone Acetate, on serum lipid and lipoprotein levels in postmenopausal women. Design Open, randomised, parallel groups study. Setting University Clinical Research Group. Population Sixty-four postmenopausal women with climacteric complaints who were otherwise healthy were screened. Of these, 58 fulfilled the entry criteria. Methods Fifty-eight postmenopausal women were randomised to receive either oral 17β-oestradiol/oestriol (Trisequens) or transdermal 17β-oestradiol (Estrapak) together with cyclical addition of Norethisterone Acetate for 48 weeks. Main outcome measures Serum levels of total cholesterol, triglycerides, high density lipoproteins (HDL), low density lipoproteins (LDL), very low density lipoproteins (VLDL), apolipoproteins, and lipoprotein(a) at baseline, and after 46 weeks (oestrogen-alone phase), and 48 weeks (oestrogen-progestogen phase) of treatment. Results Oral oestradiol therapy did not affect serum total cholesterol levels during the oestrogen-alone phase, but during the combined phase there was a 5% fall (P < 0.05) due to a 7% decrease in LDL cholesterol levels (P < 0.01). Oral therapy also increased serum triglyceride levels by 9.4% during the oestrogen-alone phase (P < 0.05). During the combined phase of transdermal therapy, there was a 19% fall in serum triglyceride levels (P < 0.05) and a 6%, fall in HDL levels (P < 0.05). Oral oestradiol reduced lipoprotein(a) levels by 31% during the oestrogen-alone phase and by 37% with Norethisterone Acetate addition (P < 0.05). Transdermal therapy had no significant effect on lipoprotein(a). Conclusions Other than a minor fall in HDL, in women receiving transdermal 17β-oestradiol, co-administration of oral progestogen in general improved, rather than worsened, this serum lipoprotein profile.
