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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands
Netherlands Institute for Neuroscience	Amsterdam	The Netherlands

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.07.2025

Trial locations

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.

Investigated diseases:

Insomnia

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 ID:

2024-512071-12-00

Protocol code:

NL87156.018.24

NCT ID:

NCT06306404

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?