NCT00530582

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
Last Updated

September 17, 2007

Status Verified

September 1, 2007

First QC Date

September 14, 2007

Last Update Submit

September 14, 2007

Conditions

HealthyPostmenopausal

Keywords

progesterone, postmenopause, sleep-EEG

Outcome Measures

Primary Outcomes (1)

  • sleep-EEG parameters

Interventions

progesteroneDRUG

300mg progesterone /placebo each for 21 days

Also known as: Utrogest/ Utrogest Placebo Ch.-B.: 0503

Eligibility Criteria

Age54 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Sleeping disorder
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Axel Steiger, Prof., MD

    Max-Planck-Institute of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2007

First Posted

September 17, 2007

Study Start

November 1, 2003

Study Completion

July 1, 2004

Last Updated

September 17, 2007

Record last verified: 2007-09

Locations

DE(1)