BridgeMD
A randomized, double-blind, placebo-controlled, multicenter study evaluating the effect of a 12-week DHEA combination of 20 mg and 2 mg prolonged-release melatonin on sleep quality and mood in postmenopausal women.
EU CTIS ID: 2024-520234-30-00
What this study is testing
Demonstration that 12-week supplementation with 20 mg DHEA and 2 mg sustained-release melatonin improves sleep quality and reduces daytime sleepiness. Demonstration that supplementation with 20 mg DHEA and 2 mg sustained-release melatonin improves mood and reduces the severity of vasomotor symptoms associated with menopause.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- woman, BMI 20.0-29.9 kg / m2, the time since the last menstruation for at least 12 months, stable body weight during the last 6 months, FSH concentration 35-135 mIU / ml and estradiol 5-55 pg / ml, total testosterone concentration 0.084 - 0.481 ng / ml, score on the Athens Insomnia Scale> 6 points, Beck Depression Score 11–27 points, Kupperman Scale score 17-30 points, Epworth scale score, no use of menopausal replacement therapy for at least 6 months, The ability to understand audit procedures and provide written informed consent.
You likely can't join if
- Current use of menopausal replacement therapy, The use of phytoestrogens, The use of psychotropic drugs, Taking sleeping pills, - Use of oral or intravenous glucocorticosteroids, Vaginal application of DHEA (Prasteron), Current or history of oncological disease, Decompensated thyroid disease or other endocrine disease such as Cushing's syndrome, Diagnosed obstructive sleep apnea, Uncontrolled cardiovascular diseases (hypertension, coronary artery disease, heart failure), Osteoarthritis with significant pain ailments with the use of steroid therapy, Rheumatoid arthritis and other rheumatological diseases with the use of steroids, A disease of the nervous system that may affect sleep disturbances, History of mental illness (except postmenopausal depression), The patient's lack of cooperation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.