Abstract:
OBJECTIVE:A phase I single centre, open label study of the pharmacokinetics and tolerability of a buccal testosterone tablet (COL 1621) was carried out. DESIGN:Twelve testosterone-deficient males were treated with the buccal tablet twice daily for 7 consecutive days. Multiple blood samples were drawn for testosterone, dihydrotestosterone (DHT), bioavailable testosterone and sex hormone-binding globulin (SHBG). RESULTS:After COL 1621, means+/-S.D. serum testosterone level increased to a peak concentration of 26.6+/-5.8 nmol/l (7.7+/-1.7 ng/ml) at 4.8+/-5.8 h and stayed in the eugonadal range. Steady state was achieved within the first 24 h and was maintained in the normal range. The bioavailable testosterone, DHT and free testosterone index followed a pattern very similar to that of testosterone. The mean serum testosterone to DHT ratio was within the normal male range throughout treatment. There was only one treatment-related adverse event (headache). Two-thirds of patients indicated that treatment with COL 1621 was acceptable and that the tablet was convenient to use. Six patients (50.0%) preferred COL 1621 to their previous testosterone replacement therapy, two patients gave preference to their previous treatment and three patients found both treatments to be equally acceptable. Data for one patient was not available. CONCLUSION:We conclude that COL 1621 can efficiently elevate serum testosterone and DHT levels in hypogonadal men within the first day of application, achieve a steady state within 24 h and maintain serum testosterone in the normal range with a twice-daily treatment regimen. COL 1621 provides an effective alternative oral testosterone replacement therapy that gives physiological levels of testosterone and is well tolerated by the patients.
journal_name
Eur J Endocrinoljournal_title
European journal of endocrinologyauthors
Ross RJ,Jabbar A,Jones TH,Roberts B,Dunkley K,Hall J,Long A,Levine H,Cullen DRdoi
10.1530/eje.0.1500057subject
Has Abstractpub_date
2004-01-01 00:00:00pages
57-63issue
1eissn
0804-4643issn
1479-683Xjournal_volume
150pub_type
临床试验,杂志文章abstract:OBJECTIVE:Recent observational studies have established progression and recurrence rates of pituitary adenomas. However, it is still unknown how individual pituitary adenomas grow over years and whether growth kinetics follow a distinct growth model. The objective of this study was to define a growth model for non-func...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/EJE-07-0502
更新日期:2008-03-01 00:00:00
abstract:CONTEXT:Acromegaly is a rare disease associated with chronic multisystem complications. National registries have been created in several countries. DESIGN:The French Registry contains data on acromegaly epidemiology, management and comorbidities recorded over more than three decades, retrospectively until 1999 and pro...
journal_title:European journal of endocrinology
pub_type: 杂志文章,多中心研究
doi:10.1530/EJE-16-1064
更新日期:2017-05-01 00:00:00
abstract:OBJECTIVE:A sex determining gene(s) has been mapped to a approximately 700 kb region distal to the exons of DMRT1 on 9p. The aim of this study was to examine gonadal developmental status in XX patients hemizygous for the 9p sex determining region. DESIGN:Clinical and molecular studies were performed in an 8-year-old g...
journal_title:European journal of endocrinology
pub_type: 临床试验,杂志文章
doi:10.1530/eje.0.1450613
更新日期:2001-11-01 00:00:00
abstract:OBJECTIVE:Modest elevations in circulating IGF-I levels have been suggested to protect against the development of glucose intolerance in insulin-resistant subjects. To further understand the interactions of GH and IGF-I on beta-cell function and post-load glucose tolerance in glucose-intolerant subjects predisposed to ...
journal_title:European journal of endocrinology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1530/eje.0.1510039
更新日期:2004-07-01 00:00:00
abstract:Background:The treatment of acromegaly resistant to first-generation somatostatin receptor ligands (SRLs) is often difficult. Pegvisomant and Pasireotide LAR are mostly used in these subset of patients, as second line therapies. Choice of the type of second line therapies is difficult, since predictors of response are ...
journal_title:European journal of endocrinology
pub_type: 杂志文章
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更新日期:2021-02-01 00:00:00
abstract:OBJECTIVE:Patients with type 2 diabetes mellitus (T2DM) have an increased risk of fractures and thiazolidinediones (TZDs) increase this risk. TZDs stimulate the expression of sclerostin, a negative regulator of bone formation, in vitro. Abnormal sclerostin production may, therefore, be involved in the pathogenesis of i...
journal_title:European journal of endocrinology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1530/EJE-11-1061
更新日期:2012-04-01 00:00:00
abstract::Ipilimumab (Yervoy; Medarex and Bristol-Myers Squibb) is a human MAB against cytotoxic T-lymphocyte antigen 4, which enhances co-stimulation of cytotoxic T-lymphocytes, resulting in their proliferation and an anti-tumour response. It is licensed for the treatment of unresectable or metastatic malignant melanoma, while...
journal_title:European journal of endocrinology
pub_type: 杂志文章,评审
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1430523
更新日期:2000-10-01 00:00:00
abstract:OBJECTIVE:This study aimed to analyze the autonomic control of heart rate variability (HRV) in subjects receiving chronic l-thyroxine (l-T4) treatment after total thyroidectomy and (131)I therapy for differentiated thyroid carcinoma. METHODS:Blood pressure (BP) and sympatho-vagal activity (evaluated by power spectral ...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.1.01918
更新日期:2005-06-01 00:00:00
abstract:OBJECTIVE:Autosomal dominant hypocalcemia (ADH) is characterized by hypocalcemia and inappropriately low PTH concentrations. ADH type 1 is caused by activating mutations in the calcium-sensing receptor (CASR), a G-protein-coupled receptor signaling through α11 (Gα11) and αq (Gαq) subunits. Heterozygous activating mutat...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/EJE-16-0109
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abstract:OBJECTIVE:Adiponectin and resistin have been linked to inflammation, endothelial dysfunction, and/or insulin secretion or resistance. It remains to be elucidated which of these adipokines is associated primarily with biomarkers of all or only some of these categories, i.e. biomarkers of inflammation, endothelial dysfun...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/EJE-09-0555
更新日期:2010-02-01 00:00:00
abstract::We measured serum tumour necrosis factor-alpha (TNF-alpha) as well as interleukin-1betta (IL-1beta) and GH concentrations in 15 children with isolated growth hormone deficiency (GHD), age range 5.1-13.9 years, before and 4 and 24h after the first GH injection (0.1 IU/kg s.c.). No differences were found in basal concen...
journal_title:European journal of endocrinology
pub_type: 临床试验,杂志文章
doi:10.1530/eje.0.1380640
更新日期:1998-06-01 00:00:00
abstract:OBJECTIVE:Both animal and human studies have associated the endocannabinoid system with obesity and markers of metabolic dysfunction. Blockade of the cannabinoid receptor 1 (CB1) caused weight loss and reduction in waist size in both obese and type II diabetics. Recent studies on common variants of the CB1 receptor gen...
journal_title:European journal of endocrinology
pub_type: 杂志文章,随机对照试验
doi:10.1530/EJE-10-0192
更新日期:2010-09-01 00:00:00
abstract::The reduced activity of the growth hormone (GH)-insulin-like growth factor I (IGF-I) axis in aging may contribute to changes in body composition. As this GH insufficiency is due to hypothalamic pathogenesis, the availability of GH-releasing peptides (GHRPs), such as GHRP-6 (His-D-Trp-Ala-Trp-D-Phe-Lys-NH2) which is ac...
journal_title:European journal of endocrinology
pub_type: 临床试验,杂志文章
doi:10.1530/eje.0.1310499
更新日期:1994-11-01 00:00:00
abstract:OBJECTIVE:Prolactin is capable of both trophic and lytic actions in rat corpora lutea. In corpora lutea responding to a trophic prolactin signal, the long form of the prolactin receptor is the dominant form and is upregulated by prolactin. We investigated whether mRNA for the short form of the prolactin receptor was do...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1430285
更新日期:2000-08-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.1.02145
更新日期:2006-05-01 00:00:00
abstract::Dogs kept under controlled photoperiodic conditions of 12 h light and 12 h dark expressed a clear diurnal melatonin rhythm in the peripheral blood, with a swift peak restricted to the late part of the scotophase. The highest density of high-affinity, G-protein-linked 2-[125I]iodomelatonin binding sites was found in th...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1310191
更新日期:1994-08-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1500345
更新日期:2004-03-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章,评审
doi:10.1530/EJE-07-0348
更新日期:2007-10-01 00:00:00
abstract::Fibrous dysplasia/McCune-Albright Syndrome (FD/MAS), arising from gain-of-function mutations in Gαs, and cutaneous skeletal hypophosphatemia syndrome (CSHS), arising from gain-of-function mutations in the Ras/MAPK pathway, are strikingly complex, mosaic diseases with overlapping phenotypes. Both disorders are defined ...
journal_title:European journal of endocrinology
pub_type: 杂志文章,评审
doi:10.1530/EJE-19-0969
更新日期:2020-05-01 00:00:00
abstract:OBJECTIVE:Inactivating mutations of the GH-releasing hormone receptor (GHRHR) gene (GHRHR) cause familial isolated GH deficiency (IGHD) type IB. The GH response to physical exercise (PE) in patients lacking GHRHR has never been studied. We hypothesized that subjects lacking functional GHRHR may be a model to study GH r...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1470591
更新日期:2002-11-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1530/eje.0.1500215
更新日期:2004-02-01 00:00:00
abstract::We examined excretion of urinary insulin-like growth factors I and II (IGF-I and IGF-II) and their major binding protein IGFBP-3 in comparison to their respective serum concentration in nine healthy female volunteers (median age 25 years, range 22-27) under baseline conditions and after stimulation with recombinant hu...
journal_title:European journal of endocrinology
pub_type: 临床试验,杂志文章
doi:10.1530/eje.0.1320433
更新日期:1995-04-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1440139
更新日期:2001-02-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1490343
更新日期:2003-10-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/EJE-07-0259
更新日期:2007-08-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/EJE-16-0639
更新日期:2016-11-01 00:00:00
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journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/eje.0.1380421
更新日期:1998-04-01 00:00:00
abstract:OBJECTIVE:Cushing's disease (CD) is usually caused by ACTH-secreting pituitary microadenomas, while silent corticotroph adenomas (SCA) are macroadenomas without Cushingoid features. However, the molecular mechanism(s) underlying their different tumor growth remains unknown. The aim of the current study was to evaluate ...
journal_title:European journal of endocrinology
pub_type: 杂志文章
doi:10.1530/EJE-10-0245
更新日期:2010-10-01 00:00:00