HealthyPhase 4NCT00530582
Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women
A Phase 4 study testing progesterone in people with Healthy and Postmenopausal, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 54 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Postmenopausal
- What is being tested?
- progesterone
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2003to Jul 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 54 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- Gastrointestinal disorder
- Gynecological disorder
- Heart and lung disorder
- Liver and kidney disorders
- Creatinin serum >2,5 mg%
- Thyroid diseases
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Objectives/ Mode of administration: To characterise the effects of progesterone in a dose of 300mg each for 21 days on changes of sleep EEG and cognition in postmenopausal healthy women, in comparison with placebo.
Methodology:The study was performed as double blind randomized placebo controlled crossover design with two treatment intervals of 21 days duration separated by 2 weeks washout. Progesterone was administered as tablets in a dose of 300mg each for 21 days. At the beginning and the end of the two intervals a sleep EEG was recorded after one night of adaptation to laboratory conditions, during which EEG electrodes were attached without recording an EEG.For the registration nights the subjects arrived at the sleep laboratory at 21.00 h. Sleep EEG was recorded from 23.00 h until 07.00 h hours next morning.Cognitive performance was tested after the registration nights at 09.00h.All pharmacodynamic investigations were carried out in the sleep laboratory of the Max Planck Institute of Psychiatry in Munich.
Main criteria for inclusion: Subjects consisted of 10 healthy women (age: range 54-70 years) who entered the study after passing rigid psychiatric, physical and laboratory examinations. They had been drug free at least 4 weeks. Reasons for exclusion from the study were: psychiatric disorder in the subjects own or family history, including dementia or other cognitive impairment; recent stressful life events; substance abuse; a transmeridian flight during the last three months; shift work; medical illness; and aberrations in blood chemistry or in the waking EEG or electrocardiogram.All subjects underwent a polysomnographic examination in the sleep laboratory before entering the study to exclude sleep disorder including sleep related respiratory disorders and sleep related movement disorders.
Statistical methode: Expolatory and inferential statistical analysis of certain aggregated sleep variables after classifying the sleep EEG in dinstinct stages according to Rechtschafen/Kales and of the results of EEG spectral analysis. Inferential statistics were based on multivariate analyses of variance (MANOVAs) with treatment as influential factor and on one sample t-tests for placebo related power changes of progesterone in non-REM sleep as well.
- Conditions
- Healthy, Postmenopausal
- Being tested
- progesterone
- Keywords
- progesterone, postmenopause, sleep-EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesteroneDrug
Also called Utrogest/ Utrogest Placebo Ch.-B.: 0503
300mg progesterone /placebo each for 21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep-EEG parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startNov 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Kade/Besins Pharma GmbH, Rigistr. 2, 12277 Berlin
- Investigators
- Axel Steiger, Prof., MD, Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530582
- Sponsor's protocol ID
- KAD 108 ex
- Status last verified
- Sep 2007
- First submitted
- 14 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00530582
- Acronym / sponsor ID
- KAD 108 ex
- Conditions
- Healthy, Postmenopausal
- Keywords
- progesterone, postmenopause, sleep-EEG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Collaborators
- Dr. Kade/Besins Pharma GmbH, Rigistr. 2, 12277 Berlin
- Study start
- Nov 2003
- Study completion
- Jul 2004 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Objectives/ Mode of administration: To characterise the effects of progesterone in a dose of 300mg each for 21 days on changes of sleep EEG and cognition in postmenopausal healthy women, in comparison with placebo.
Methodology:The study was performed as double blind randomized placebo controlled crossover design with two treatment intervals of 21 days duration separated by 2 weeks washout. Progesterone was administered as tablets in a dose of 300mg each for 21 days. At the beginning and the end of the two intervals a sleep EEG was recorded after one night of adaptation to laboratory conditions, during which EEG electrodes were attached without recording an EEG.For the registration nights the subjects arrived at the sleep laboratory at 21.00 h. Sleep EEG was recorded from 23.00 h until 07.00 h hours next morning.Cognitive performance was tested after the registration nights at 09.00h.All pharmacodynamic investigations were carried out in the sleep laboratory of the Max Planck Institute of Psychiatry in Munich.
Main criteria for inclusion: Subjects consisted of 10 healthy women (age: range 54-70 years) who entered the study after passing rigid psychiatric, physical and laboratory examinations. They had been drug free at least 4 weeks. Reasons for exclusion from the study were: psychiatric disorder in the subjects own or family history, including dementia or other cognitive impairment; recent stressful life events; substance abuse; a transmeridian flight during the last three months; shift work; medical illness; and aberrations in blood chemistry or in the waking EEG or electrocardiogram.All subjects underwent a polysomnographic examination in the sleep laboratory before entering the study to exclude sleep disorder including sleep related respiratory disorders and sleep related movement disorders.
Statistical methode: Expolatory and inferential statistical analysis of certain aggregated sleep variables after classifying the sleep EEG in dinstinct stages according to Rechtschafen/Kales and of the results of EEG spectral analysis. Inferential statistics were based on multivariate analyses of variance (MANOVAs) with treatment as influential factor and on one sample t-tests for placebo related power changes of progesterone in non-REM sleep as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 54 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (23 listed)
- Gastrointestinal disorder
- Gynecological disorder
- Heart and lung disorder
- Liver and kidney disorders
- Creatinin serum >2,5 mg%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progesteroneAlso: Utrogest/ Utrogest Placebo Ch.-B.: 0503300mg progesterone /placebo each for 21 days | Drug | – |
Primary outcome
sleep-EEG parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2007.
- BackgroundDzaja 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Steiger, Prof., MD principal investigator
Max-Planck-Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing progesterone in people with Healthy and Postmenopausal, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep-EEG parameters. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2007.