Study on the Effects of DHEA and Melatonin on Sleep and Mood in Postmenopausal Women with Sleep Disorders

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What is this study about?

This clinical trial is focused on studying the effects of a combination treatment on sleep quality and mood in women who have gone through menopause. Menopause is a natural phase in a woman’s life when her menstrual periods stop permanently, and she can no longer become pregnant. During this time, many women experience sleep disorders and mood changes. The treatment being studied includes two medications: DHEA (20 mg) and melatonin (2 mg), which is a prolonged-release tablet. DHEA is a hormone that the body naturally produces, and melatonin is a hormone that helps regulate sleep.

The purpose of this study is to see if taking these medications together for 12 weeks can improve sleep quality and mood in postmenopausal women. The study will also look at whether this combination can reduce daytime sleepiness and the severity of symptoms like hot flashes, which are common during menopause. Participants will be randomly assigned to receive either the medication combination or a placebo, and neither the participants nor the researchers will know who is receiving which treatment until the study is completed.

Throughout the study, participants will take the medication or placebo orally, meaning by mouth, for a period of 12 weeks. The study will monitor changes in sleep quality, mood, and menopausal symptoms. Additionally, the study will assess the effects of the treatment on certain hormone levels in the blood. This research aims to provide more information on how these medications might help improve the quality of life for women experiencing menopause-related issues.

1 introduction to the study

Upon joining the study, the participant will receive an overview of the trial’s purpose and procedures. The study aims to evaluate the effects of a 12-week treatment on sleep quality and mood in postmenopausal women.

2 medication administration

Participants will be administered two types of tablets: Senaxa PR, which contains 2 mg of prolonged-release melatonin, and Biosteron, which contains 10 mg of prasterone (also known as DHEA).

Both medications are taken orally. The melatonin tablet is designed to release the active ingredient slowly over time, while the prasterone tablet is a standard form.

3 treatment duration

The treatment will last for a total of 12 weeks. During this period, participants will take the prescribed medications daily as directed.

4 monitoring and assessments

Throughout the study, participants will undergo regular assessments to monitor the effects of the treatment on sleep quality, mood, and menopausal symptoms.

These assessments will include evaluations of sleep patterns, mood changes, and any reduction in menopausal symptoms such as hot flashes.

5 end of study

At the conclusion of the 12-week period, participants will have a final assessment to evaluate the overall impact of the treatment.

The primary focus will be on improvements in sleep quality and mood, as well as any changes in menopausal symptoms.

Who Can Join the Study?

Must be a woman.
Body Mass Index (BMI) should be between 20.0 and 29.9 kg/m². BMI is a measure of body fat based on height and weight.
Must have had no menstruation for at least 12 months.
Body weight should have been stable for the last 6 months.
FSH concentration should be between 35-135 mIU/ml. FSH is a hormone related to reproductive processes.
Estradiol levels should be between 5-55 pg/ml. Estradiol is a form of estrogen, a female hormone.
Total testosterone concentration should be between 0.084 – 0.481 ng/ml. Testosterone is a hormone found in both men and women.
Score on the Athens Insomnia Scale should be more than 6 points. This scale measures sleep difficulties.
Beck Depression Score should be between 11-27 points. This score assesses the level of depression.
Kupperman Scale score should be between 17-30 points. This scale measures symptoms related to menopause.
Must have a score on the Epworth scale. This scale measures daytime sleepiness.
No use of menopausal replacement therapy for at least 6 months. This therapy involves taking hormones to relieve menopause symptoms.
Must be able to understand the study procedures and provide written informed consent.

Who Cannot Join the Study?

Men who wish to participate cannot join, as the study is only for women.
Individuals who are not experiencing menopause or related sleep disorders cannot participate.
People who are not within the specified age range for the study cannot join. The study is for a specific age group.
Participants who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ezrzfqwjtx Rjklcefc &wdtm Sisyavg Cylhkt Soc z oqsd	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	30.11.2024

Trial locations

Investigated drugs:

DHEA is a hormone that is naturally produced by the body. In this study, it is being used to see if it can help improve sleep quality and mood in postmenopausal women. The researchers are interested in whether DHEA can reduce daytime sleepiness and improve overall well-being.

Melatonin is a hormone that helps regulate sleep. In this trial, a prolonged-release form of melatonin is being used. This means it is designed to be released slowly into the body over time. The goal is to see if it can help improve sleep quality and mood in postmenopausal women, as well as reduce symptoms like hot flashes that are common during menopause.

Investigated diseases:

Menopause

Menopause – Menopause is a natural biological process that marks the end of a woman’s menstrual cycles, typically occurring in middle age. It is diagnosed after 12 months without a menstrual period. During this time, the body undergoes significant hormonal changes, leading to symptoms such as hot flashes, night sweats, and mood swings. These changes can also affect sleep patterns and lead to sleep disorders. The transition can vary greatly among women, with some experiencing mild symptoms and others facing more severe disruptions.

Sleep Disorders in the Postmenopausal Period – Sleep disorders during the postmenopausal period are common and can include difficulties falling asleep, staying asleep, or waking up too early. These issues are often linked to hormonal changes that occur during menopause, such as decreased levels of estrogen and progesterone. Women may experience increased nighttime awakenings and a reduction in deep sleep stages. This can lead to daytime fatigue, irritability, and difficulty concentrating. The severity and type of sleep disturbances can vary widely among individuals.

Trial ID:

2024-520234-30-00

Protocol code:

DHM/EPH/01/2022

Trial Phase:

Therapeutic confirmatory (Phase III)

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