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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520234-30-00

Acronym

DHM/EPH/01/2022

Enrollment

100

Registered

2025-01-30

Start date

2024-11-30

Completion date

Unknown

Last updated

2025-05-13

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

Brief summary

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.

Detailed description

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.

Interventions

DRUGtabletki

DRUGBiosteron

DRUG10 mg

DRUGSenaxa PR

DRUG2 mg

DRUGtabletki o przedłużonym uwalnianiu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026