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.

Phase 1

• Conditions: Menopause; Therapeutic area: Health Care [N] - Population Characteristics [N01]

• Registration Number: EUCTR2023-000224-10-PL
• Lead Sponsor: The Pharmaceutical Company LEK-AM Sp. Zo.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-12
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 100

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Demonstration that 35 mg DHEA supplementation <br>affects serum levels of LH, DHEAS and estradiol;Timepoint(s) of evaluation of this end point: N/A