Continuous-combined treatment of the menopause with combinations of oestradiol valerate and dienogest — a dose-ranging study

Gräser, T; Müller, Alexandra; Mellinger, Uwe; Mück, A. O.; Th, Lippert; Oettel, M

doi:10.1016/s0378-5122(00)00112-2

Cited by 20 publications

(10 citation statements)

References 13 publications

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“…It is a novel progestin combining the typical pharmacokinetic and pharmacodynamic properties of the 19-norprogestins with those of progesterone derivatives [52,53]. Combined with EV 2 mg, it has been proved in different HRT studies to be safe and effective in the treatment of climacteric complaints [54][55][56][57].…”

Section: Methodsmentioning

confidence: 99%

Brain Regions Activated during an Auditory Discrimination Task in Insomniac Postmenopausal Patients before and after Hormone Replacement Therapy: Low-Resolution Brain Electromagnetic Tomography Applied to Event-Related Potentials

Anderer

Saletu²,

Saletu-Zyhlarz³

et al. 2004

Neuropsychobiology

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Electrical sources of auditory event-related potentials (ERPs) determined by means of low-resolution brain electromagnetic tomography (LORETA) in 48 unmedicated insomniac postmenopausal patients aged between 46 and 67 years were compared with those obtained in 48 age-matched normal female controls. Subsequently, the patients were included in a double-blind, placebo-controlled, comparative, randomized 3-arm trial phase – Climodien 2/3 [estradiol valerate (EV) 2 mg + the progestin dienogest 3 mg] was compared with EV 2 mg and placebo – followed by an open-label phase in which all of them received Climodien 2/2 (EV 2 mg + dienogest 2 mg). The double-blind and the open-label phase lasted 2 months. ERPs were recorded from 19 EEG leads in a two-tone oddball paradigm and electrical sources of standard N1 and P2 as well as target N2 and P300 components were estimated. In both patients and controls, LORETA revealed an activation of the superior temporal gyrus [auditory cortex, Brodmann areas (BA) 41, 42, 22] for all four components. For standard P2, an additional activation was observed medially parietally in the precuneus (BA 7, 5). For target N2, also a medial frontal source (BA 9, 10, 32) was identified. Finally, for the target P300 component – in addition to the aforementioned sources – activations in the prefrontal cortex (BA 9, 10, 46, 47), the inferior parietal cortex (supramarginal gyrus, BA 40, 39) and the posterior cingulum (BA 31) were found. Thus, patients and controls did not differ in the structural processes engaged in these fundamental aspects of information processing. However, patients demonstrated significantly reduced source strength – for standard ERP components predominantly in the temporal lobe and for target components predominantly in the frontal lobe, indicating reduced energetic resources available for perceptual and cognitive demands of the discrimination task. While, as compared with placebo, estrogen alone had only minor effects on ERP source strength, Climodien generally increased the impressed current density at the ERP peak latencies, predominantly in the temporal lobe, indicating an increased stimulus-induced cortical arousal in the primary and higher-order auditory cortex. Specifically, Climodien enhanced P300 source strength in the left middle temporal gyrus and in the left superior frontal gyrus, brain regions that on the one hand have been shown to be affected by hormone therapy in positron emission tomography and functional magnetic resonance neuroimaging studies and that on the other hand are among those critical for encoding and memory processes.

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Section: Methodsmentioning

confidence: 99%

Brain Regions Activated during an Auditory Discrimination Task in Insomniac Postmenopausal Patients before and after Hormone Replacement Therapy: Low-Resolution Brain Electromagnetic Tomography Applied to Event-Related Potentials

Anderer

Saletu²,

Saletu-Zyhlarz³

et al. 2004

Neuropsychobiology

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“…DNG has been reported to exhibit high selectivity for binding to progesterone receptors (6) and to have antiproliferative activity in isolated human endometrial cells (8) and inhibitory effects on the secretion of cytokines in endometriotic stromal cells (9). It has been reported that DNG decreased proliferative appearances in endometrium in a dose-dependent manner at daily doses of 0.5 mg or more (15). Consequently, not only the lowering effect of DNG on the serum estradiol concentration but also its inhibitory effects on endometrial cell proliferation may contribute to its efficacy.…”

Section: Harada Dienogest Versus Buserelin In Endometriosis Fertil mentioning

confidence: 99%

Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial

Harada

Momoeda

Taketani

et al. 2009

Fertility and Sterility

215

159

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“…In a dose-finding study including five combinations of 2 mg estradiol valerate with 0.5, 1, 2, 3 and 4 mg dienogest, the dosages with 2 and 3 mg of the progestin were selected on the basis of efficacy and endometrial safety for further clinical development 13 . Later, these combinations were tested in a double-blind fashion against Kliogest Ò with respect to their efficacy to prevent endometrial hyperplasia 14 .…”

Section: Introductionmentioning

confidence: 99%

Climodien^®(estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints

Gräser¹,

Römer²,

Wiedey³

et al. 2001

Climacteric

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Continuous-combined treatment of the menopause with combinations of oestradiol valerate and dienogest — a dose-ranging study

Cited by 20 publications

References 13 publications

Brain Regions Activated during an Auditory Discrimination Task in Insomniac Postmenopausal Patients before and after Hormone Replacement Therapy: Low-Resolution Brain Electromagnetic Tomography Applied to Event-Related Potentials

Brain Regions Activated during an Auditory Discrimination Task in Insomniac Postmenopausal Patients before and after Hormone Replacement Therapy: Low-Resolution Brain Electromagnetic Tomography Applied to Event-Related Potentials

Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial

Climodien^®(estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints

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Continuous-combined treatment of the menopause with combinations of oestradiol valerate and dienogest — a dose-ranging study

Cited by 20 publications

References 13 publications

Brain Regions Activated during an Auditory Discrimination Task in Insomniac Postmenopausal Patients before and after Hormone Replacement Therapy: Low-Resolution Brain Electromagnetic Tomography Applied to Event-Related Potentials

Brain Regions Activated during an Auditory Discrimination Task in Insomniac Postmenopausal Patients before and after Hormone Replacement Therapy: Low-Resolution Brain Electromagnetic Tomography Applied to Event-Related Potentials

Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial

Climodien®(estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints

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Climodien^®(estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints