Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women
Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 4
Details
Lead Sponsor:
Max-Planck-Institute of Psychiatry
Collaborator:
Dr. Kade/Besins Pharma GmbH, Rigistr. 2, 12277 Berlin