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).
Status | Completed |
Enrollment | 10 |
Est. completion date | July 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 54 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Healthy female elderly subjects - Age between 55-70 years - Normal physical examination including a neurological and gynecological examination - Medical history without major or chronic diseases (e.g. diabetes, heart failure, hepatitis) - No previous psychiatric or chronic neurological disorder (e.g. schizophrenia, epilepsy) - Normal standard electrocardiograpy (ECG) - Normal laboratory results - Body Mass Index <30 - Normal sleep EEG concerning restless leg and sleep apnoe syndrom - Normal EEG, according to the guidelines of the Deutsche EEG Gesellschaft (German EEG Society) - Written informed consent - Written consent from the gynecologist, who examined the subjects, that there is no contradiction for the oral application of Utrogest Exclusion Criteria: - Gastrointestinal disorder - Gynecological disorder - Heart and lung disorder - Liver and kidney disorders - Creatinin serum >2,5 mg% - Thyroid diseases - Psychiatric disorders - Psychiatric disorder in the family history - Peripheral and central nervous system disorder - Metabolic diseases - Endocrine diseases - Muscular or dermatological diseases - Haematological diseases - Smoker Further exclusion criteria were: - Sleeping disorder - Shift work - Transmerdian flight in the last three months - Malignant diseases - Acute infective diseases - Clinically relevant allergies - Lack of compliance to study procedures - Participation in another clinical study within the last 4 month |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Max Planck Institute of Psychiatry | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Max-Planck-Institute of Psychiatry | Dr. Kade/Besins Pharma GmbH, Rigistr. 2, 12277 Berlin |
Germany,
Dzaja A, Arber S, Hislop J, Kerkhofs M, Kopp C, Pollmacher T, Polo-Kantola P, Skene DJ, Stenuit P, Tobler I, Porkka-Heiskanen T. Women's sleep in health and disease. J Psychiatr Res. 2005 Jan;39(1):55-76. Ehlers CL, Kupfer DJ. Slow-wave sleep: do young adult men and women age differently? J Sleep Res. 1997 Sep;6(3):211-5. Friess E, Tagaya H, Trachsel L, Holsboer F, Rupprecht R. Progesterone-induced changes in sleep in male subjects. American Journal of Physiology: Endocrinology & Metabolism 1997; 272:E885-E891. Grön G, Friess E, Herpers M, Rupprecht R. Assessment of cognitive performance after progesterone administration in healthy male volunteers. Biol Psychiatry 1997; 35:147-151. Heuser G, Ling GM, Kluver M. Sleep induction by progesterone in the pre-optic area in cats. Electroencephalography & Clinical Neurophysiology 1966; 22:122-127. Lancel M, Faulhaber J, Schiffelholz T, Romeo E, Di Michele F, Holsboer F, Rupprecht R. Allopregnanolone affects sleep in a benzodiazepine-like fashion. Journal of Pharmacology & Experimental Therapeutics 1997; 282(3):1213-1218. Montplaisir J, Lorrain J, Denesle R, Petit D. Sleep in menopause: differential effects of two forms of hormone replacement therapy. Menopause 2001;10-16. Steiger A, Trachsel L, Guldner J, Hemmeter U, Rothe B, Rupprecht R, Vedder H, Holsboer F. Neurosteroid pregnenolone induces sleep-EEG changes in man compatible with inverse agonistic GABAA-receptor modulation. Brain Research 1993; 615:267-274.
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---|---|---|---|---|
Primary | sleep-EEG parameters |
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