Prasterone (DHEA) for Menopause|Postmenopausal sleep disorder

Inclusion criteria

• {"criterion_text":"- woman\n- BMI 20.0-29.9 kg / m2\n- the time since the last menstruation for at least 12 months\n- stable body weight during the last 6 months\n- FSH concentration 35-135 mIU / ml and estradiol 5-55 pg / ml\n- total testosterone concentration 0.084 - 0.481 ng / ml\n- score on the Athens Insomnia Scale> 6 points\n- Beck Depression Score 11–27 points\n- Kupperman Scale score 17-30 points\n- Epworth scale score\n- no use of menopausal replacement therapy for at least 6 months\n- The ability to understand audit procedures and provide written informed consent."}

Exclusion criteria

• {"criterion_text":"- Current use of menopausal replacement therapy\n- The use of phytoestrogens\n- The use of psychotropic drugs\n- Taking sleeping pills\n- Use of oral or intravenous glucocorticosteroids\n- Vaginal application of DHEA (Prasteron)\n- Current or history of oncological disease\n- Decompensated thyroid disease or other endocrine disease such as Cushing's syndrome\n- Diagnosed obstructive sleep apnea\n- Uncontrolled cardiovascular diseases (hypertension, coronary artery disease, heart failure)\n- Osteoarthritis with significant pain ailments with the use of steroid therapy\n- Rheumatoid arthritis and other rheumatological diseases with the use of steroids\n- A disease of the nervous system that may affect sleep disturbances\n- History of mental illness (except postmenopausal depression)\n- The patient's lack of cooperation"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Not explicitly specified in the primary endpoint text. Inclusion criteria reference assessment scales (Athens Insomnia Scale, Beck Depression Score, Kupperman Scale, Epworth scale) which are likely used to assess sleep quality, mood and daytime sleepiness."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement of serum concentrations of DHEAS, estradiol, LH and SHBG (serum assays) as stated in the endpoint text."}

Poland

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

9

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

The Pharmaceutical Company LEK-AM Sp. Zoo.

Organisation Type

Industry

Country Of Registered Address

Poland