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AzTrials

MenopausePhase 4NCT06117969

the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

A Phase 4 study testing Tibolone, Xiangshao granules and Tibolone plus Xiangshao granules in people with Menopause and Sleep Disorder, run by Peking Union Medical College Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for menopausal symptoms, meanwhile, traditional Chinese medicine is also effective to some extent. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Menopause, Sleep Disorder
What is being tested?
Tibolone, Xiangshao granules and Tibolone plus Xiangshao granules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
30 Dec 2023to 30 Sep 2025
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 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • women aged 40-60
  • natural menopause for 1-10 years
  • PSQI score >=11 points
  • improved K-score>=14 points
  • able to independently sign informed consent forms

Who cannot join

  • Vaginal bleeding of unknown cause
  • Known or suspected breast cancer and other sex hormone dependent tumors
  • Active venous or arterial thromboembolic disease within past 6 months
  • Have used sex hormone or traditional Chinese medicine/botanical drugs that affect menopausal symptoms within the past month
  • Have used anti anxiety, depression drugs or sedative hypnotics within the past month
  • Patients with anxiety or depression above moderate level
Show all 10Show fewer
  • Severe liver or kidney dysfunction, with transaminase or creatinine level exceeding twice of the normal value
  • BMI ≥ 28 kg/m2
  • Allergies to research drugs
  • Other situations that doctor deems unsuitable to participate in the study

Trial locations and contacts

No sites are listed yet.

Rong Chen, Professor contact

010-13811030947

chenrongpumch@163.com

Lingjin Yang contact

010-15650795133

yanglingjin0803@126.com

About this study

Official title: A Prospective Randomized Controlled Study of the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for menopausal symptoms, meanwhile, traditional Chinese medicine is also effective to some extent. This prospective randomized controlled study plan to compare the effects of different therapy regimens, including Tibolone and Xiangshao granules, on menopausal sleep disorders.

Being tested
Tibolone, Xiangshao granules, Tibolone plus Xiangshao granules
Medical subject headings
Sleep Wake Disorders

What participants receive

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

  • TiboloneDrug

    1.25mg po qd

  • Xiangshao granulesDrug

    4g po tid

  • Tibolone plus Xiangshao granulesDrug

    Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid

Study groups in NCT06117969
Study groupRoleWhat they receive
TiboloneExperimentaltake Tibolone 1.25mg/day orally for 8 weeks
Receives: Drug: Tibolone
Xiangshao granulesExperimentaltake Xiangshao granules orally 3 times a day, 4g each time
Receives: Drug: Xiangshao granules
Tibolone plus Xiangshao granulesExperimentaltake Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks
Receives: Drug: Tibolone plus Xiangshao granules

What is being measured

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

  1. Polysomnography (PSG)

    Extract PSG EEG data: record time, bed time, sleep time, awakening time, rapid eye movement sleep time (REM), non rapid eye movement sleep time (NREM), non rapid eye movement sleep phase 1 (N1), non rapid eye movement sleep phase 2 (N2), non rapid eye movement sleep phase 3 (N3), total sleep time (TST), sleep latency (SL), wake after sleep onset (WASO), sleep efficiency (SE).

    Measured: V0(screening period), V3(week 8)

  2. Pittsburgh Sleep QualityIndex questionnaire (PSQI questionnaire)

    The total score of PSQI questionnaire is 0-21 points. Normal sleep quality is defined as less than 11 points.

    Measured: V0(screening period), V2(week 4), V3(week 8)

  3. Sleep diary

    Sleep diary is recorded by study participants daily.

    Measured: V0(screening period), V1（dsy 1）, V2(week 4), V3(week 8)

Secondary outcomes (4)

  1. Improved Kupperman score

    The total score of improved K score is graded into four levels: normal(<7), mild(7-14), moderate(15-29), severe(>30).

    Measured: V0(screening period), V2(week 4), V3(week 8)

  2. Menopause-specific Quality of Life Scale

    Evaluate vasomotor symptoms, psychological and emotional symptoms, physical symptoms and sexual activity symptoms. Choose a level from "0-6" based on the degree to which this symptom affects subject. ''0'' means it doesn't affect subject at all; ''6'' indicates extreme impact on subject.

    Measured: V0(screening period), V2(week 4), V3(week 8)

  3. Self-Rating Anxiety Scale

    Assess anxiety level over the past two weeks. The evaluation adopts a 1-4 scoring system, where the scores of 20 questions are added together to obtain the total score. The total score is multiplied by 1.25 and rounded to the nearest whole number to obtain the standard score. The cut-off value of SAS standard score is 50 points, with a score of 50-59 indicating mild anxiety, 60-69 indicating moderate anxiety, and a score above 70 indicating severe anxiety.

    Measured: V0(screening period), V2(week 4), V3(week 8)

  4. Center for Epidemiological Survey Depression Scale (CES Depression Scale)

    The total score of CES-D is graded into three levels: asymptomatic(<15), possible depressive symptoms(16-19), existed depressive symptoms(≥20)

    Measured: V0(screening period), V2(week 4), V3(week 8)

Timeline

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

  1. First posted7 Nov 2023
  2. Study start30 Dec 2023 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion30 Sep 2025 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06117969
Sponsor's protocol ID
menopausal sleep disorders
Status last verified
Oct 2023
First submitted
16 Oct 2023
Last updated
2 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moline ML, Broch L, Zak R, Gross V. Sleep in women across the life cycle from adulthood through menopause. Sleep Med Rev. 2003 Apr;7(2):155-77. doi: 10.1053/smrv.2001.0228.

    PubMed 12628216

  • Gold EB, Sternfeld B, Kelsey JL, Brown C, Mouton C, Reame N, Salamone L, Stellato R. Relation of demographic and lifestyle factors to symptoms in a multi-racial/ethnic population of women 40-55 years of age. Am J Epidemiol. 2000 Sep 1;152(5):463-73. doi: 10.1093/aje/152.5.463.

    PubMed 10981461

  • Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.

    PubMed 28875581

  • Kaplan KA, Hardas PP, Redline S, Zeitzer JM; Sleep Heart Health Study Research Group. Correlates of sleep quality in midlife and beyond: a machine learning analysis. Sleep Med. 2017 Jun;34:162-167. doi: 10.1016/j.sleep.2017.03.004. Epub 2017 Mar 27.

    PubMed 28522086

  • Kenemans P, Speroff L; International Tibolone Consensus Group. Tibolone: clinical recommendations and practical guidelines. A report of the International Tibolone Consensus Group. Maturitas. 2005 May 16;51(1):21-8. doi: 10.1016/j.maturitas.2005.02.011.

    PubMed 15883105

  • Jiang XR, Ren L, Li CR. [Effect of Electroacupuncture on Hypothalamus-Pituitary-Ovary (HPO) Axis in Rats with Peri-menopausal Depression]. Zhen Ci Yan Jiu. 2017 Feb 25;42(1):45-9. Chinese.

    PubMed 29071997

  • Chen R, Tang R, Zhang S, Wang Y, Wang R, Ouyang Y, Xie X, Liu H, Lv S, Shi H, Zhang Y, Xie M, Luo Y, Yu Q. Xiangshao granules can relieve emotional symptoms in menopausal women: a randomized controlled trial. Climacteric. 2021 Jun;24(3):246-252. doi: 10.1080/13697137.2020.1820476. Epub 2020 Oct 5.

    PubMed 33016149

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tibolone, Xiangshao granules and Tibolone plus Xiangshao granules in people with Menopause and Sleep Disorder, run by Peking Union Medical College Hospital.

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 10 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rong Chen, Professor (010-13811030947, chenrongpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Polysomnography (PSG) (time frame: V0(screening period), V3(week 8)). The study lists 3 primary outcomes in all. 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 NCT06117969, which also lists 7 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 2 Jan 2024.

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