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Insomniac Postmenopausal WomenPhase 3NCT01501422

Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

A Phase 3 study testing Estrogen patch in people with Insomniac Postmenopausal Women, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. Sex hormone including estrogen have synergistic effect to serotonin activity and decrease activity of monoamine oxidase activity so the norepinephrine is not be metabolized, these substance are important to regulate hemostasis and circadian process of sleep 2. Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Insomniac Postmenopausal Women
What is being tested?
Estrogen patch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteThailand
Study dates
Jul 2011to Jan 2012
Phase
Phase 3
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 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Postmenopausal women 40-60 years old
  • Mild to moderate vasomotor symptom
  • Insomnia
  • fluent read and write in Thai language
  • Inform consent

Who cannot join

  • Acute liver and gall bladder disease
  • undiagnosed abnormal bleeding per vagina
  • History of BIRADs 3 from mammogram
  • History or current venous thrombosis, embolism
  • diagnosis of sleep disorder
  • use of hypnotic drug or antihistamine in the past month
Show all 11Show fewer
  • Diagnosis of psychiatric disorder such as depressive disorder, schizophrenia, anxiety disorder
  • No past history of malignancy
  • No history of chronic renal disease, alzheimer's disease, uncontrolled hypertension, uncontrolled diabetes mellitus
  • history of estrogen use in past 6 months
  • drug abuse, Alcohol

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital

    Pathumwan, Bangkok, 10330

Other trials in Thailand

About this study

Official title: Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women at Menopause Clinic, King Chulalongkorn Memorial Hospital, Double- Blind, Randomized, Placebo-controlled Trial

  1. Sex hormone including estrogen have synergistic effect to serotonin activity and decrease activity of monoamine oxidase activity so the norepinephrine is not be metabolized, these substance are important to regulate hemostasis and circadian process of sleep
  2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion
  • GABA substance is in order to initiate sleep and continue sleep
  1. According to epidemiologic data, problem of sleep was increasing in postmenopause group compare to premenopause group (aged-match)
  2. This research perform to find out the actual effect of estrogen in improving sleep quality.
Read the detailed description
  1. 40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom were screened and included in project
  2. Block of four randomization was use to categorize participants into 2 groups
  • Study group (estrogen patch)
  • Control group (placebo patch)
  1. Sleep quality was measured before intervention by subjective and objective sleep quality
  • Subjective sleep quality (self sleep questionnaire)
  • Objective sleep quality (wrist actigraphy and sleep diary): wrist actigraph sleep test at home for 1 week
  1. Intervention phase : continuous use of weekly patch for 8 weeks
  • Estrogen patch in study group
  • Placebo patch in control group
  1. Follow up phase
  • At 4 weeks of use, investigator will telephone call for follow up the participant's compliance and the side effects during patch use.
  • After completed use of 7th patch, sleep quality was measured again, self sleep quality questionnaire and 1 week-wrist actigraphy and sleep diary test
  1. Then the data will be analysed and open label, in nonhysterectomized postmenopausal women in study group will take the medroxyprogesterone acetate for washing out the endometrium for 2 weeks
  2. The participants will be counseled, further investigate and proper treatment.
Being tested
Estrogen patch, Placebo
Keywords
postmenopause, sleep quality, estrogen, objective sleep quality, actigraph
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estrogen patchDrug

    50 microgram estrogen patch weekly

  • PlaceboDrug

    Placebo patch for 8 weeks

Study groups in NCT01501422
Study groupRoleWhat they receive
EstrogenExperimentalUse estrogen patch for 8 weeks
Receives: Drug: Estrogen patch
PlaceboExperimentalUse placebo patch for 8 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep efficiency (SE)

    Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed.

    Measured: 8 months

Secondary outcomes (5)

  1. Sleep latency (SL)

    Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep.

    Measured: 8 months

  2. Total sleep time (TST)

    TST is amount of actual sleep time in a sleep period.

    Measured: 8 months

  3. Wake time after sleep onset (WASO)

    WASO is the total time of awake occurring between sleep onset and final wake up.

    Measured: 8 months

  4. Number of awakening

    Number of awakening is the number of awakening during onset of sleep and final wake-up.

    Measured: 8 months

  5. Score of two sleep quality assessment questionnaires.

    • Insomnia severity index is the 7 topic questionnaire for determine the severity of insomnia problem.
    • Ebworth severity index is the questionnaire to assess daytime sleepiness.

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01501422
Sponsor's protocol ID
MRU CU-1/2011
Status last verified
Dec 2012
First submitted
14 Nov 2011
Last updated
28 Dec 2012
Results posted
No
Data monitoring committee
No

Publications

  • Kalleinen N, Polo O, Himanen SL, Joutsen A, Polo-Kantola P. The effect of estrogen plus progestin treatment on sleep: a randomized, placebo-controlled, double-blind trial in premenopausal and late postmenopausal women. Climacteric. 2008 Jun;11(3):233-43. doi: 10.1080/13697130802112033.

    PubMed 18568788

  • Huang KE, Baber R; Asia Pacific Tibolone Consensus Group. Updated clinical recommendations for the use of tibolone in Asian women. Climacteric. 2010 Aug;13(4):317-27. doi: 10.3109/13697131003681458.

    PubMed 20443720

  • Halbreich U, Kahn LS. Role of estrogen in the aetiology and treatment of mood disorders. CNS Drugs. 2001;15(10):797-817. doi: 10.2165/00023210-200115100-00005.

    PubMed 11602005

  • Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and treatment of hot flashes. Mayo Clin Proc. 2002 Nov;77(11):1207-18. doi: 10.4065/77.11.1207.

    PubMed 12440557

  • Sarti CD, Chiantera A, Graziottin A, Ognisanti F, Sidoli C, Mincigrucci M, Parazzini F; Gruppo di Studio IperAOGOI. Hormone therapy and sleep quality in women around menopause. Menopause. 2005 Sep-Oct;12(5):545-51. doi: 10.1097/01.gme.0000172270.70690.5e. Epub 2005 Sep 1.

    PubMed 16145308

  • Wiklund I, Berg G, Hammar M, Karlberg J, Lindgren R, Sandin K. Long-term effect of transdermal hormonal therapy on aspects of quality of life in postmenopausal women. Maturitas. 1992 Mar;14(3):225-36. doi: 10.1016/0378-5122(92)90117-m.

    PubMed 1508062

  • Polo-Kantola P, Erkkola R, Helenius H, Irjala K, Polo O. When does estrogen replacement therapy improve sleep quality? Am J Obstet Gynecol. 1998 May;178(5):1002-9. doi: 10.1016/s0002-9378(98)70539-3.

    PubMed 9609575

  • Saletu B. Sleep, vigilance and cognition in postmenopausal women: placebo-controlled studies with 2 mg estradiol valerate, with and without 3 mg dienogest. Climacteric. 2003 Aug;6 Suppl 2:37-45.

    PubMed 14669843

  • Ensrud KE, Stone KL, Blackwell TL, Sawaya GF, Tagliaferri M, Diem SJ, Grady D. Frequency and severity of hot flashes and sleep disturbance in postmenopausal women with hot flashes. Menopause. 2009 Mar-Apr;16(2):286-92. doi: 10.1097/gme.0b013e31818c0485.

    PubMed 19002015

  • Tranah GJ, Parimi N, Blackwell T, Ancoli-Israel S, Ensrud KE, Cauley JA, Redline S, Lane N, Paudel ML, Hillier TA, Yaffe K, Cummings SR, Stone KL. Postmenopausal hormones and sleep quality in the elderly: a population based study. BMC Womens Health. 2010 May 4;10:15. doi: 10.1186/1472-6874-10-15.

    PubMed 20441593

  • Tansupswatdikul P, Chaikittisilpa S, Jaimchariyatam N, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N. Effects of estrogen therapy on postmenopausal sleep quality regardless of vasomotor symptoms: a randomized trial. Climacteric. 2015 Apr;18(2):198-204. doi: 10.3109/13697137.2014.964670. Epub 2014 Nov 27.

    PubMed 25242569

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Estrogen patch in people with Insomniac Postmenopausal Women, run by Chulalongkorn University at 1 site in Thailand.

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 5 inclusion and 11 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 28 Dec 2012. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 efficiency (SE) (time frame: 8 months). 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 NCT01501422, which also lists 11 linked publications.

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 28 Dec 2012.

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