Effect of Menopausal Hormone Therapy on Sleep

NCT07674316 | Active Not Recruiting DMC

• 1 other identifier: 2024-00345
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

The Effect of Menopausal Hormone Therapy on Sleep (menoSLEEP) study is investigating the effects of menopausal hormone therapy (MHT) on sleep problems in peri- and postmenopausal women with an indication for MHT. The aim of the study is to find out whether MHT improves subjective and objective sleep quality in these women. The primary objective is to measure sleep quality using several sleep-specific questionnaires and a sleep protocol. The study is a multicentre, prospective, unblinded, randomised controlled trial involving 172 women. Participants will be divided into groups that will either receive MHT or act as a control group. All participants will complete seven questionnaires before and after MHT and keep a sleep diary. The duration of participation will vary between 8 and 16 weeks. The results should help to improve the treatment of menopausal sleep disorders and the quality of life of women affected.

Conditions

Menopause; Sleep Quality; Psychological Wellbeing

Keywords

HRT; Hormone Replacement Therapy; Menopause; Sleep

Outcome Measures

Primary Outcomes (2)

• Sleep Quality

  Sleep quality measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 0 to 4, yielding a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity and poorer sleep quality.

  8-16 weeks

• Sleep Quality

  Subjective sleep quality assessed using a 2-week sleep protocol with daily ratings on a 9-point Likert scale (range: 1-9). Higher scores indicate better subjective sleep quality.

  8-16 weeks

Secondary Outcomes (14)

• Sleep duration (total sleep time)

  8-16 weeks

• Sleep Latency

  8-16 weeks

• Wake-time after sleep onset

  8-16 weeks

• Time in bed (TIB)

  8-16 weeks

• Sleep Efficiency (SE)

  8-16 weeks

Study Arms (4)

Postmenopausal women with direct start of HRT

Postmenopausal women with direct start of HRT

Drug: HRT

Postmenopausal control group: postmenopausal women with delayed start of HRT

Postmenopausal control group: postmenopausal women with delayed start of HRT

Drug: HRT

Perimenopausal women with direct start of HRT

Perimenopausal women with direct start of HRT

Drug: HRT

Perimenopausal control group: perimenopausal women with delayed start of HRT

Perimenopausal control group: perimenopausal women with delayed start of HRT

Drug: HRT

Interventions

HRT DRUG

HRT

Perimenopausal control group: perimenopausal women with delayed start of HRT; Perimenopausal women with direct start of HRT; Postmenopausal control group: postmenopausal women with delayed start of HRT; Postmenopausal women with direct start of HRT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People with XX genome
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy peri- and postemenopausal women with an indication for HRT

You may qualify if:

• Informed Consent as documented by signature
• Peri- and postmenopausal woman
• Indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.)
• Age ≥ 18 years
• German Speaking

You may not qualify if:

• Obesity BMI ≥ 30 kg/m²
• Pregnancy or Lactation
• Status post Hysterectomy
• Systemic hormone therapy or hormonal contraception (estrogens, progestogens, androgens) during the study and within 12 weeks prior to study entry
• Prescribed medication for therapy of sleep problems 12 weeks prior to study entry (excluding phytotherapeutic agents and over the counter medication)
• Medication that could distort sleep (e.g. antidepressant, anticonvulsant and antipsychotic medications)
• Substance abuse (e.g. daily alcohol consumption, drugs in general)
• Contraindication for menopausal hormone therapy according to swissmedicinfo.ch
• Neoplasia of the breast or other sexual organ
• Benign or malignant liver tumors
• Acute or chronic liver disease
• Cholestatic jaundice
• Porphyria
• Arterial or venous thromboembolic events
• Abnormal genital bleeding of unknown cause

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern, Frauenklinik

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Susanna Weidlinger, Dr. med.

  Inselspital Bern, Universitätsklinik für Frauenheilkunde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: June 29, 2026
• Study Start: May 1, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 01.02.2025 - 01.02.2027
• Access Criteria: That depends on the situation.

Locations

CH (1)