Menopause (New York, N.Y.) · 2009
Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Labrie Fernand, Archer David, Bouchard Céline, Fortier Michel, Cusan Leonello, Gomez José-Luis, Girard Ginette, Baron Mira, Ayotte Normand, Moreau Michèle, Dubé Robert, Côté Isabelle, Labrie Claude, Lavoie Lyne, Bérubé René, Bélanger Patrick, Berger Louise, Gilbert Lucy, Martel Céline, Balser John
Аннотация
OBJECTIVE: Because a previous 1-week study has shown no or minimal changes in the serum levels of dehydroepiandrosterone (DHEA) and its metabolites after up to daily 1.8% (23.4 mg) intravaginal DHEA, the objective of the present study was to investigate the serum steroid levels during a 12-week daily intravaginal administration of 0%, 0.25%, 0.5%, and 1.0% DHEA (Prasterone) 1.3 mL ovules.
METHODS: In a double-blind, placebo-controlled phase III study, 218 postmenopausal women (age range, 42-74 y) were randomized to receive daily one of four DHEA concentrations intravaginally. Serum steroids were measured by a Good Laboratory Practice-validated mass spectrometry technology in samples obtained at time of visit.
RESULTS: The serum levels of DHEA and 11 of its metabolites measured at screening, day 1, and weeks 2, 4, 8, and 12 in women showed no or minimal changes during the whole observation period, with all values remaining well within the limits of normal postmenopausal women. No accumulation of the steroid metabolites nor change in DHEA bioavailability was detected.
CONCLUSIONS: The present data show that local daily intravaginal DHEA administration at DHEA doses of 3.25-13 mg was able to rapidly and efficiently achieve correction of all the signs and symptoms of vaginal atrophy and improve sexual function and caused no or minimal changes in serum sex steroid levels, which all remain within the normal postmenopausal range, thus avoiding the risks of all estrogen formulations.
METHODS: In a double-blind, placebo-controlled phase III study, 218 postmenopausal women (age range, 42-74 y) were randomized to receive daily one of four DHEA concentrations intravaginally. Serum steroids were measured by a Good Laboratory Practice-validated mass spectrometry technology in samples obtained at time of visit.
RESULTS: The serum levels of DHEA and 11 of its metabolites measured at screening, day 1, and weeks 2, 4, 8, and 12 in women showed no or minimal changes during the whole observation period, with all values remaining well within the limits of normal postmenopausal women. No accumulation of the steroid metabolites nor change in DHEA bioavailability was detected.
CONCLUSIONS: The present data show that local daily intravaginal DHEA administration at DHEA doses of 3.25-13 mg was able to rapidly and efficiently achieve correction of all the signs and symptoms of vaginal atrophy and improve sexual function and caused no or minimal changes in serum sex steroid levels, which all remain within the normal postmenopausal range, thus avoiding the risks of all estrogen formulations.
Предметные рубрики MeSH
Administration, IntravaginalAgedAtrophyBiological AvailabilityDehydroepiandrosteroneDose-Response Relationship, DrugDouble-Blind MethodDrug MonitoringEstradiolFemaleHormone Replacement TherapyHumansMass SpectrometryMiddle AgedPostmenopauseProspective StudiesSexual Dysfunction, PhysiologicalTime FactorsVagina