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.

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. - DHM/EPH/01/2022

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-004160-16-PL

Enrollment

100

Registered

2023-11-08

Start date

2024-02-22

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, sleep disorders in the postmenopausal period

Interventions

Trade Name: Biosteron 10 mg, Senaxa PR Product Name: DHEA and Melatonin Product Code: PR1-777-2022, PR2-777-2022 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: Demonstration that DHEA supplementation at a dose of 20 mg and 2 mg of sustained-release melatonin affects the concentration of DHEAS and estradiol.;Primary end point(s): The primary endpoints of this study are to evaluate the effects of 12 weeks of DHEA 20 mg and 2 mg sustained-release melatonin on sleep quality in postmenopausal women and on mood and reduction of menopausal vasomotor symptoms.;Timepoint(s) of evaluation of this end point: N/A	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: Demonstration that DHEA supplementation at a dose of 20 mg and 2 mg of sustained-release melatonin affects the concentration of DHEAS and estradiol.;Primary end point(s): The primary endpoints of this study are to evaluate the effects of 12 weeks of DHEA 20 mg and 2 mg sustained-release melatonin on sleep quality in postmenopausal women and on mood and reduction of menopausal vasomotor symptoms.;Timepoint(s) of evaluation of this end point: N/A

—

Secondary

Measure	Time frame
Secondary end point(s): Assessment of the effect of 12-week administration of DHEA in a dose of 20 mg and 2 mg of sustained-release melatonin on the serum concentration of DHEAS, estradiol, LH and SHBG.;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Poland

Contacts

Public ContactCRO Clinical Trial

Europharma M. Rachtan Sp. z o.o.

europharma@europharma.edu.pl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026