Ongoing Clinical Trials for Menopausal Symptoms
There are currently 3 clinical trials investigating different treatments for menopausal symptoms, including sleep disturbances, mood changes, and other common issues women experience during menopause. These trials are taking place across several European countries and are testing various hormonal and non-hormonal treatments to help improve quality of life for women going through this natural transition.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Germany
- Netherlands
- Poland
- Spain
- Sweden
Study on the Effects of DHEA and Melatonin on Sleep and Mood in Postmenopausal Women with Sleep Disorders
This trial is investigating how a combination of two medications, DHEA and melatonin, might help improve sleep quality and mood in women who have gone through menopause and are experiencing sleep problems.
Inclusion criteria: Women who can participate in this study must have had no menstrual period for at least 12 months and have a Body Mass Index between 20.0 and 29.9 kg/m². They should have stable body weight for the past 6 months and specific hormone levels within certain ranges, including FSH between 35-135 mIU/ml, estradiol between 5-55 pg/ml, and testosterone between 0.084-0.481 ng/ml. Participants must score more than 6 points on the Athens Insomnia Scale, which measures sleep difficulties, and have a Beck Depression Score between 11-27 points. They should also score between 17-30 points on the Kupperman Scale, which measures menopause symptoms. Women must not have used menopausal hormone replacement therapy for at least 6 months before joining the study.
Exclusion criteria: Men cannot participate in this study, as it is specifically designed for women. Additionally, individuals who are not experiencing menopause or related sleep disorders, those outside the specified age range, and people who belong to vulnerable populations requiring special protection are not eligible.
Study focus: The trial will last 12 weeks, during which participants will take DHEA (20 mg) and prolonged-release melatonin (2 mg) tablets daily. The study aims to evaluate whether this combination can improve sleep quality, reduce daytime sleepiness, improve mood, and decrease the severity of common menopausal symptoms like hot flashes. Participants will be randomly assigned to receive either the active medications or a placebo, and neither they nor the researchers will know who is receiving which treatment until the study ends. Throughout the study, regular assessments will monitor changes in sleep patterns, mood, and hormone levels in the blood.
Investigational drugs: DHEA is a hormone naturally produced by the body that is being studied to see if it can help improve sleep quality and overall well-being in postmenopausal women. Melatonin is a hormone that helps regulate sleep, and in this trial, a prolonged-release form is being used, designed to release slowly into the body over time to potentially improve sleep quality and reduce symptoms like hot flashes.
Study on the Safety of Micronized Progesterone and Norethisterone Acetate with Estradiol for Menopausal Symptoms in Women
This clinical trial is examining the safety of two different hormone therapy approaches for women experiencing menopausal symptoms such as hot flashes, sweating, and sleep problems. The study compares micronized progesterone and norethisterone acetate, both combined with estradiol.
Inclusion criteria: Healthy, naturally postmenopausal women aged 45-60 years who are experiencing symptoms like sweating, hot flushes, and sleep problems that affect their quality of life can participate. Women must have a Body Mass Index between 19 and 32 kg/m² and have an intact uterus. To be considered postmenopausal, participants must not have had a menstrual period for more than one year or have an FSH hormone level greater than 40 IE/L. If women have previously used menopausal hormone therapy, they must stop oral therapy for 8 weeks and transdermal or local estrogen treatment for 4 weeks before screening. All participants must provide written informed consent.
Exclusion criteria: Only females can participate in this study. Men and individuals belonging to vulnerable populations that might need special protection or care are not eligible.
Study focus: The study will last one year and is designed to be double-blind, meaning neither participants nor researchers will know which treatment each woman is receiving. Participants will be randomly assigned to receive either micronized progesterone or norethisterone acetate, both combined with estradiol. The primary focus is on comparing the effects of these treatments on breast and endometrial health. Throughout the study, participants will undergo regular check-ups, including mammograms to assess breast density and ultrasounds to evaluate the thickness of the uterine lining. The study will also monitor bleeding patterns and various health-related quality of life measures, along with blood tests to analyze hormone levels.
Investigational drugs: Micronized progesterone is a form of progesterone processed into tiny particles to improve absorption when taken orally. In this study, it is used with estrogen to assess its safety and effects on breast and endometrial health. Norethisterone acetate is a synthetic form of progesterone used alongside estrogen to compare its effects on breast density with micronized progesterone. Estradiol is a form of estrogen that plays a crucial role in the female reproductive system and is combined with either progesterone option to evaluate safety and effects on breast and endometrial health.
Study on Elinzanetant for Treating Sleep Disturbances in Menopausal Women
This trial is investigating a medication called elinzanetant for its potential to help women experiencing sleep problems during menopause. The medication is being compared to a placebo to assess its effectiveness and safety.
Inclusion criteria: Women aged 40 to 65 years who are in the post-menopausal period can participate. To be considered postmenopausal, women should have serum FSH levels greater than 40 mIU/mL and serum estradiol levels less than 30 pg/mL. Women who have had their uterus surgically removed must have had the procedure at least 6 weeks before joining the study. Participants should have a history of sleep problems related to menopause, such as waking up at night or having poor quality sleep. Specifically, they should have an average wake time after initially falling asleep of 30 minutes or more, based on two sleep tests, with neither night being less than 20 minutes.
Exclusion criteria: Men cannot participate as the study is only for women. Women who are not experiencing menopause-related sleep disturbances, individuals outside the specified age range, and those who are part of vulnerable populations requiring special protection or care are not eligible.
Study focus: The treatment period lasts for 12 weeks, during which participants take elinzanetant or a placebo in the form of a soft capsule. The study uses polysomnography, a method that records sleep activity, to establish baseline sleep patterns and to measure changes at weeks 4 and 12. The primary goal is to assess changes in wake time after sleep onset and sleep efficiency. Throughout the study, participants are monitored for any side effects or abnormal results, with safety being a priority. Additional assessments include evaluations using sleep-related questionnaires.
Investigational drugs: Elinzanetant is a medication being studied for its potential to help with sleep disturbances during menopause. It works by modulating specific receptors in the brain involved in regulating sleep patterns and is classified as a neurokinin receptor antagonist. The trial is currently in Phase 2, where its effectiveness and safety are being evaluated compared to a placebo.
Summary
These three clinical trials represent diverse approaches to addressing the challenges women face during menopause, with a particular focus on sleep disturbances and quality of life. Two of the trials concentrate specifically on sleep problems, while one examines the broader safety profile of hormone replacement therapies.
Geographically, the trials show interesting patterns. One study is being conducted across multiple European countries including Belgium, Spain, Poland, Germany, Austria, Czechia, and the Netherlands, suggesting a larger-scale investigation. The other two trials are single-country studies in Poland and Sweden respectively. This distribution reflects both national research priorities and the need for diverse populations in clinical research.
The treatments being investigated range from traditional hormone therapies combining progesterone and estrogen, to a hormone and sleep aid combination using DHEA and melatonin, to a novel medication called elinzanetant that works on brain receptors involved in sleep regulation. This variety demonstrates the ongoing search for both improved safety profiles and more effective treatments for menopausal symptoms, recognizing that different women may benefit from different therapeutic approaches.
