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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Max-Planck-Institute of Psychiatry
• Collaborator: Dr. Kade/Besins Pharma GmbH, Rigistr. 2, 12277 Berlin
• Treatments: Progesterone

Criteria

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