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Study on the Effects of Estradiol, Progesterone, and Online Sleep Therapy for Insomnia and Menopausal Symptoms in Perimenopausal Women

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how different treatments can help with insomnia and climacteric symptoms, which are common during the perimenopause phase. Perimenopause is the time when a woman's body transitions towards menopause, often leading to sleep problems and mood changes. The study will explore the effects of two treatments: a hormone therapy using a transdermal patch called Systen 50, which contains estradiol, and a capsule called Utrogestan, which contains progesterone. Additionally, the study will include a guided online program designed to improve sleep and mood.

The purpose of the study is to evaluate how effective these treatments are, both individually and in combination, in improving sleep and mood in women experiencing perimenopause. Participants will use the hormone therapy and the online program over a period of time, and their progress will be monitored. The study will also use devices like the Hypnodyne ZMax Total and the Empatica EmbracePlus wristband to track sleep patterns and other health indicators at home.

The study will last several months, with participants being assessed at different stages to see how their symptoms change over time. The goal is to find ways to reduce mental health complaints and improve overall well-being for women going through perimenopause. This research aims to provide valuable insights into managing symptoms associated with this phase of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to evaluate eligibility based on specific criteria such as age (40-55 years), insomnia severity, and climacteric symptoms.

    Participants must be capable of completing online questionnaires and diaries in Dutch and English.

  2. Step 2

    Baseline measurement

    Baseline measurements are taken to assess insomnia severity using the Insomnia Severity Index (ISI).

    Additional assessments include sleep efficiency, depressive symptoms, and climacteric symptoms.

  3. Step 3

    Treatment phase 1

    Participants receive hormone therapy using Systen 50 transdermal patches, delivering 50 micrograms of estradiol every 24 hours.

    Additionally, Utrogestan capsules containing micronised progesterone are administered orally.

    The treatment aims to address insomnia and depressive symptoms over a period of 2 months.

  4. Step 4

    Evaluation at 2 months

    After 2 months, insomnia severity is reassessed to determine changes from baseline.

    Other outcomes such as sleep efficiency, depressive symptoms, and climacteric symptoms are also evaluated.

  5. Step 5

    Treatment phase 2

    Participants continue with the hormone therapy and may also engage in a guided online cognitive behavioral therapy for insomnia (CBTi) with a circadian rhythm stabilization (CRS) component.

    This phase lasts for an additional 2 months, focusing on further improvement of mental health and well-being.

  6. Step 6

    Evaluation at 4 months

    At the end of 4 months, a final assessment is conducted to measure changes in insomnia severity and other health outcomes compared to baseline.

    The effectiveness of the combined treatment approach is evaluated.

Who can join the trial?

5 criteria

  • Be a woman aged between 40 and 55 years old.
  • Have an Insomnia Severity Index score of 10 or higher. This is a way to measure how severe your insomnia is.
  • Have a Green Climacteric Score of 13 or higher. This score helps to assess symptoms related to menopause.
  • Feel confident in your ability to complete online questionnaires and diaries in Dutch and English.
  • Have a menstrual cycle, meaning it has been less than one year since your last period.

Who cannot join the trial?

4 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who are not experiencing **insomnia** or **climacteric symptoms** cannot participate. **Insomnia** means having trouble sleeping, and **climacteric symptoms** are changes that occur during menopause, like hot flashes or mood swings.
  • People who are not in the **perimenopausal** stage cannot participate. **Perimenopausal** refers to the time when a woman's body is transitioning towards menopause.
  • Individuals who are considered part of a **vulnerable population** cannot participate. A **vulnerable population** includes groups of people who might need special protection, like children or those with certain disabilities.
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Verified sites

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  • Stichting OLVG

    Verified

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

  • Hormone Therapy (MHT)

    is used in this study to help manage symptoms related to menopause, such as hot flashes and mood swings. It involves taking hormones to replace those that the body no longer produces after menopause. This therapy aims to improve overall well-being and reduce menopausal symptoms.

  • Guided Online Cognitive Behavioral Therapy for Insomnia (CBTi)

    is a structured program that helps individuals change thoughts and behaviors that cause or worsen sleep problems. This therapy is delivered online and is designed to improve sleep quality and reduce insomnia symptoms.

  • CRS (Cognitive Restructuring and Support)

    is a therapeutic approach included in the study to help participants manage depressive symptoms. It involves identifying and changing negative thought patterns and providing support to improve mood and mental health.

What is already known about the treatment

  • Hormone Therapy (MHT)

    This medication is administered orally or through patches applied to the skin. It is currently used in medicine to manage symptoms associated with menopause, such as hot flashes and mood swings. The main therapeutic indications include alleviating climacteric symptoms and improving sleep quality in perimenopausal women. At the molecular level, MHT works by supplementing the body with hormones like estrogen and progesterone, which decrease during menopause, helping to balance hormone levels and reduce symptoms. It is classified pharmacologically as hormone replacement therapy.

  • Guided Online Cognitive Behavioral Therapy for Insomnia (CBTi)

    This therapy is delivered through an online platform, allowing users to access sessions from home. It is recognized in medical literature as an effective non-pharmacological treatment for insomnia. The main therapeutic indication is to improve sleep patterns and reduce insomnia symptoms. The mechanism of action involves changing negative thoughts and behaviors related to sleep, promoting healthier sleep habits. It is classified as a form of cognitive behavioral therapy.

Investigated diseases

  • Insomnia

    Insomnia is a sleep disorder where individuals have trouble falling asleep, staying asleep, or waking up too early and not being able to go back to sleep. It can lead to feeling tired upon waking and can affect mood, energy levels, and overall quality of life. Insomnia can be short-term, lasting a few days or weeks, or chronic, lasting a month or more. It may be caused by stress, life events, or habits that disrupt sleep. Over time, insomnia can lead to difficulties in concentrating and performing daily tasks.

  • Climacteric Symptoms

    Climacteric symptoms refer to the physical and emotional changes that occur during the transition to menopause, known as perimenopause. These symptoms can include hot flashes, night sweats, mood swings, and sleep disturbances. The intensity and duration of these symptoms can vary widely among women. They are caused by hormonal changes as the body adjusts to lower levels of estrogen and progesterone. These symptoms can affect daily life and well-being, often requiring lifestyle adjustments.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512071-12-00Protocol codeNL87156.018.24Estimated enrolment222 patientsSponsorAmsterdam UMC Stichting

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