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Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women

NCT00530582 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2007-09-17

No results posted yet for this study

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).

Conditions

  • Healthy
  • Postmenopausal

Interventions

DRUG

progesterone

300mg progesterone /placebo each for 21 days

Sponsors & Collaborators

  • Dr. Kade/Besins Pharma GmbH, Rigistr. 2, 12277 Berlin

    collaborator UNKNOWN

  • Max-Planck-Institute of Psychiatry

    lead OTHER

Principal Investigators

  • Axel Steiger, Prof., MD · Max-Planck-Institute of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
54 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-30
Completion
2004-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530582 on ClinicalTrials.gov