Ongoing Clinical Trials for Menopause
Two clinical trials are currently investigating treatment options for postmenopausal women experiencing sleep disorders, mood changes, and bone health concerns. These studies are exploring the effects of hormone-based therapies including DHEA, melatonin, estradiol, testosterone, and triptorelin in women who have gone through menopause.
Clinical trial locations
- Denmark
- Poland
Study on the Effects of DHEA and Melatonin on Sleep and Mood in Postmenopausal Women with Sleep Disorders
This clinical trial is examining whether a combination of two medications can help improve sleep quality and mood in women after menopause. The study focuses on women who are experiencing sleep difficulties and mood changes, which are common during this life phase.
Main focus: The trial aims to evaluate whether taking DHEA (20 mg) and prolonged-release melatonin (2 mg) together for 12 weeks can improve sleep quality and mood in postmenopausal women. Researchers will also monitor whether this combination reduces daytime sleepiness and menopausal symptoms such as hot flashes. The study is designed as a randomized trial where participants will receive either the medication combination or a placebo, and neither participants nor researchers will know who receives which treatment until the study ends.
Who can participate: The trial is looking for women who have not had menstruation for at least 12 months, with a BMI between 20.0 and 29.9 kg/m2. Participants should have stable body weight for the past six months and specific hormone levels within defined ranges, including FSH between 35-135 mIU/ml, estradiol between 5-55 pg/ml, and total testosterone between 0.084-0.481 ng/ml. Women should score more than 6 points on the Athens Insomnia Scale, between 11-27 points on the Beck Depression Score, and between 17-30 points on the Kupperman Scale. Participants must not have used menopausal replacement therapy for at least six months and must be able to understand study procedures and provide written consent.
Who cannot participate: Men cannot join this trial as it is specifically designed for women. Women who are not experiencing menopause or related sleep disorders, those not within the specified age range, and individuals considered part of a vulnerable population are not eligible.
Investigational drugs: The trial uses DHEA, a hormone naturally produced by the body, to see if it can improve sleep quality and mood while reducing daytime sleepiness. The prolonged-release melatonin helps regulate sleep by releasing slowly into the body over time, with the goal of improving sleep quality, mood, and reducing hot flashes common during menopause.
Evaluation of triptorelin, estradiol, and testosterone compared to placebo for changes in bone markers in postmenopausal women
This study is investigating how different hormone treatments affect bone health in women after menopause. The research compares the effects of several treatments including triptorelin injections, estradiol gel applied to the skin, testosterone gel applied to the skin, and placebo.
Main focus: The trial aims to evaluate changes in bone health markers over an 8-week period in postmenopausal women. Participants are divided into four groups, each receiving one of the treatments: triptorelin injection into the muscle, transdermal estradiol gel, transdermal testosterone gel, or placebo. Throughout the study, researchers monitor changes in bone health markers, hormone levels, quality of life, sleep patterns, and other health indicators through regular check-ups and blood tests.
Who can participate: The study is seeking women between 40 and 65 years old with a BMI between 18 and 35. Participants must be in confirmed menopause and experiencing moderate to severe vasomotor symptoms, meaning hot flashes and night sweats that significantly affect daily life.
Who cannot participate: Women currently taking hormone replacement therapy, those with a history of breast cancer or other hormone-dependent cancers, and those with osteoporosis cannot join. Participants with current use of medications affecting bone metabolism, those not in postmenopausal state, and women with severe medical conditions that could interfere with the study are excluded. Additionally, women with blood clotting disorders, liver disease, uncontrolled high blood pressure, known allergies to study medications, current smoking habit, or BMI above 35 are not eligible. Those who participated in another clinical trial within the past 30 days are also excluded.
Investigational drugs: The trial uses a gonadotropin-releasing hormone analog that controls hormone levels by affecting reproductive hormone release to understand its effects on bone health. Transdermal estrogen, applied through the skin, supplements the natural estrogen that decreases during menopause to examine its impact on bone markers. Transdermal testosterone, also applied through the skin, investigates how this hormone impacts bone health markers in postmenopausal women.
Summary
The two ongoing clinical trials for menopause are taking place in different European countries: Poland and Denmark. While both studies focus on postmenopausal women, they address different aspects of health during this life phase. The Polish trial concentrates on sleep quality and mood improvements using DHEA and melatonin over a 12-week period, specifically targeting women with sleep disorders and mood changes. The Danish trial focuses on bone health markers over an 8-week period, comparing multiple hormone-based treatments including triptorelin, estradiol, and testosterone.
Both studies reflect the growing interest in hormone-based therapies for managing menopause-related symptoms. The trials differ in their approach: one uses oral medications while the other primarily employs transdermal (through-the-skin) applications and injections. These studies may provide valuable information about treatment options for women experiencing various challenges during the postmenopausal period, from sleep disturbances to bone health concerns.
