Healthy Clinical Trial
Official title:
Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women
Sleep is impaired in postmenopausal women (difficulty falling asleep, frequent awakenings).
Progesterone prompted benzodiazepine-like effects on sleep EEG in young normal male
subjects.
Aim of this study was to test if replacement therapy with progesterone improves sleep after
menopause.
Design, Setting, and Participants: A double blind cross-over design study with 2 treatment
intervals of 21 days duration separated by a 2 weeks washout was performed. A oral dose of
300mg micronized progesterone was given each for 21 days. At the beginning and the end of
the two intervals a sleep EEG was recorded and cognitive performance was assessed in 10
healthy postmenopausal women (age: 54-70 yrs).
Objectives/ Mode of administration: To characterise the effects of progesterone in a dose of
300mg each for 21 days on changes of sleep EEG and cognition in postmenopausal healthy
women, in comparison with placebo.
Methodology:The study was performed as double blind randomized placebo controlled crossover
design with two treatment intervals of 21 days duration separated by 2 weeks washout.
Progesterone was administered as tablets in a dose of 300mg each for 21 days. At the
beginning and the end of the two intervals a sleep EEG was recorded after one night of
adaptation to laboratory conditions, during which EEG electrodes were attached without
recording an EEG.For the registration nights the subjects arrived at the sleep laboratory at
21.00 h. Sleep EEG was recorded from 23.00 h until 07.00 h hours next morning.Cognitive
performance was tested after the registration nights at 09.00h.All pharmacodynamic
investigations were carried out in the sleep laboratory of the Max Planck Institute of
Psychiatry in Munich.
Main criteria for inclusion: Subjects consisted of 10 healthy women (age: range 54-70 years)
who entered the study after passing rigid psychiatric, physical and laboratory examinations.
They had been drug free at least 4 weeks. Reasons for exclusion from the study were:
psychiatric disorder in the subjects own or family history, including dementia or other
cognitive impairment; recent stressful life events; substance abuse; a transmeridian flight
during the last three months; shift work; medical illness; and aberrations in blood
chemistry or in the waking EEG or electrocardiogram.All subjects underwent a
polysomnographic examination in the sleep laboratory before entering the study to exclude
sleep disorder including sleep related respiratory disorders and sleep related movement
disorders.
Statistical methode: Expolatory and inferential statistical analysis of certain aggregated
sleep variables after classifying the sleep EEG in dinstinct stages according to
Rechtschafen/Kales and of the results of EEG spectral analysis. Inferential statistics were
based on multivariate analyses of variance (MANOVAs) with treatment as influential factor
and on one sample t-tests for placebo related power changes of progesterone in non-REM sleep
as well.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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