A randomized, double-blind, placebo-controlled, multicentre study to evaluate the effect of a 12-week dose of 35 mg DHEA on quality of life in menopausal women.

A randomized, double-blind, placebo-controlled, multicentre study to evaluate the effect of a 12-week dose of 35 mg DHEA on quality of life in menopausal women. - DHEA/EPH/02/2022

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2023-000224-10-PL

Enrollment

100

Registered

2023-04-12

Start date

2023-08-17

Completion date

Unknown

Last updated

2025-03-10

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

Conditions

Menopause

Interventions

Trade Name: Biosteron 10 mg, Biosteron 25 mg Product Name: DHEA Product Code: PR1-888-2022

PR2-888-2022 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - woman, -BMI 20.0-29.9 kg / m2, - time from the last menstruation at least 12 months, -stable body weight during the last 6 months, - FSH concentration 35-135 mIU / ml and estradiol 5-55 pg / ml, - concentration of total testosterone 0.084 - 0.481 ng / ml, - Beck Depression Score 11–27 points, - result in the Kupperman Scale 17-30 points, - declared sexual activity, - FSFI scale - not using 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, - 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 - 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 the quality of life, - 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 35 mg DHEA improves quality of life and reduces symptoms of vaginal atrophy. Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the severity of vasomotor symptoms associated with menopause.;Secondary Objective: Demonstration that DHEA supplementation in a dose of 35 mg affects the concentration of DHEA and estradiol.;Primary end point(s): Demonstration that 12 weeks of supplementation with 35 mg DHEA improves quality of sexual life and reduces symptoms of vaginal atrophy. Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the severity of vasomotor symptoms associated with menopause.;Timepoint(s) of evaluation of this end point: N/A	—

Measure

Time frame

Main Objective: Demonstration that 12-week supplementation with 35 mg DHEA improves quality of life and reduces symptoms of vaginal atrophy. Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the severity of vasomotor symptoms associated with menopause.;Secondary Objective: Demonstration that DHEA supplementation in a dose of 35 mg affects the concentration of DHEA and estradiol.;Primary end point(s): Demonstration that 12 weeks of supplementation with 35 mg DHEA improves quality of sexual life and reduces symptoms of vaginal atrophy. Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the severity of vasomotor symptoms associated with menopause.;Timepoint(s) of evaluation of this end point: N/A

—

Secondary

Measure	Time frame
Secondary end point(s): Demonstration that 35 mg DHEA supplementation affects serum levels of LH, DHEAS and estradiol;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Poland

Contacts

Public ContactCRO Clinical Trial

Europharma M. Rachtan Sp. z o.o.

+4832 786 40 50

Outcome results

None listed

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