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

Registered 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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • DHEA

    This medication is taken orally and is currently being studied for its effects on sleep quality and mood in postmenopausal women. It is primarily used to address menopause-related symptoms, such as sleep disorders and mood changes. DHEA works by serving as a precursor to sex hormones, which may help balance hormone levels and improve symptoms. It is classified as a hormone supplement.

  • Melatonin (Prolonged-Release)

    Administered orally, this form of melatonin is designed to release slowly over time, and is being evaluated for its potential to enhance sleep quality and mood in postmenopausal women. It is commonly used to treat sleep disorders, particularly those related to menopause. Melatonin regulates the sleep-wake cycle by acting on receptors in the brain to promote sleep. It is classified as a sleep aid or hypnotic.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520234-30-00Protocol codeDHM/EPH/01/2022Estimated enrolment100 patientsSponsorPrzedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o.

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