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- Halbreich, Uriel, et al.
(författare)
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Clinical diagnostic criteria for premenstrual syndrome and guidelines for their quantification for research studies.
- 2007
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Ingår i: Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. - : Informa UK Limited. - 0951-3590. ; 23:3, s. 123-30
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Tidskriftsartikel (refereegranskat)abstract
- Premenstrual syndrome (PMS) encompasses a variety of symptoms appearing during the luteal phase of the menstrual cycle. Although PMS is widely recognized, the etiology remains unclear and it lacks definitive, universally accepted diagnostic criteria. To address these issues an international multidisciplinary group of experts evaluated the current definitions and diagnostic criteria of PMS and premenstrual dysphoric disorder (PMDD). Following extensive correspondence, a consensus meeting was held with the aim of producing updated diagnostic criteria for PMS and guidelines for clinical and research applications. This report presents the conclusions and recommendations of the group. It is hoped that the criteria proposed by the group will become widely accepted and eventually be incorporated into the next edition of the World Health Organization's International Classification of Diseases (ICD-11). It is also hoped that the proposed guidelines for quantification of criteria will be used by clinicians and investigators to facilitate diagnostic uniformity in the field as well as adequate treatment modalities when warranted.
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- Mueck, Alfred, et al.
(författare)
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Low-dose continuous combinations of hormone therapy and biochemical surrogate markers for vascular tone and inflammation: transdermal versus oral application.
- 2007
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Ingår i: Menopause. - : Ovid Technologies (Wolters Kluwer Health). - 1530-0374 .- 1072-3714. ; 14:6, s. 978-984
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To compare the effects of low-dose transdermal estradiol (E2)/norethisterone acetate (NETA) patches (Estalis 25/125) with low-dose oral E2/NETA (Activelle) on cardiovascular biochemical markers after 12 and 52 weeks of treatment in postmenopausal women with intact uteri. Design: Participants were randomly assigned to receive either transdermal E2/NETA (delivering daily doses of 25 [mu]g E2 and 125 [mu]g NETA, applied every 3-4 d) or oral E2/NETA (1 mg E2 and 0.5 mg NETA, given daily) in this open-label study. The following markers or their stable metabolites in serum or urine were assessed: P-selectin, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, monocyte chemoattractant protein-1, matrix metalloproteinase-9, homocysteine, cyclic guanosine monophosphate, serotonin, prostacyclin, thromboxane, and urodilatin. Results: Significant decreases were found for P-selectin, intercellular adhesion molecule-1, monocyte chemoattractant protein-1, and homocysteine for both hormone therapy (HT) regimens compared with baseline. Matrix metalloproteinase-9 was increased only by oral HT. The urinary concentrations of cyclic guanosine monophosphate, the ratio of prostacyclin to thromboxane metabolite, and the serotonin metabolite were significantly increased for both HT application modes, although the oral treatment showed a significantly greater increase than the transdermal one with respect to baseline. Urodilatin excretion was increased only by the oral regimen. Conclusions: Low-dose transdermal and oral HTs using E2 and NETA elicit favorable effects on cardiovascular biochemical markers. For most markers the magnitude of changes found were similar with respect to baseline; however, in some cases oral HT led to a significantly greater change, whereas in other cases the transdermal formulations seemed to provide greater benefits. Whether these differences may be attributed to the different administration routes or to different pharmacokinetic properties remains an open question. Overall low-dose transdermal HT seems to provoke the same benefit on the cardiovascular system as oral HT, as suggested by the results on vascular markers.
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- Samsioe, Göran, et al.
(författare)
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One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women.
- 2007
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Ingår i: Maturitas. - : Elsevier BV. - 1873-4111 .- 0378-5122. ; 57, s. 171-181
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To evaluate the safety and endometrial protection of low-dose transdermal estradiol (E2)/norethisterone acetate (NETA) patches (Estalis 25/125) in terms of post-treatment incidence of endornetrial hyperplasia/cancer after 1 year of treatment in postmenopausal women with intact uteri. Methods: Patients were randomized to receive either transdermal E2/NETA (delivering daily doses of E2 25 mu g and NETA 125 mu g; applied every 3-4 days) or oral E2/NETA (E2 1 mg and NETA 0.5 mg; given daily) in this open-label study. The primary variable was the incidence of endometrial hyperplasia/cancer based on endometrial biopsies; secondary variables included vaginal bleeding/spotting patterns, patch adhesion, safety and tolerability. Results: Six hundred and seventy-seven patients were randomized (507 in the transdermal group and 169 in the oral group; one did not receive study drug) and >80% completed the study. There were no cases of endometrial hyperplasia or cancer in either group and the upper limit of the one-sided 95% confidence interval in the transdermal group was 0.85%. Over time, both treatments were associated with a decreasing frequency of spotting/bleeding days. The overall incidence of adverse events (AEs) was comparable in both groups, and the majority was mild-to-moderate in intensity. Breast tenderness was the most frequently reported AE (transdermal 19.9% versus oral 28.4%). AEs related to the gastrointestinal system were more frequent with oral E2/NETA, and episodes of spotting and bleeding were more frequent with transdermal E2/NETA. Local skin tolerability of the transdermal matrix system was good. Conclusions: Transdermal E2/NETA (25 and 125 1 mu g) provided adequate endometrial protection in postmenopausal women when evaluated according to CPMP/CHMP criteria, achieved a high rate of amenorrhea, and was well tolerated.
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