E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Health Care [N] - Population Characteristics [N01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Wykazanie, że 12-tygodniowa suplementacja DHEA w dawce 35 mg poprawia jakość życia i zmniejsza objawy atrofii pochwy. Wykazanie, że suplementacja DHEA w dawce 35 mg poprawia nastrój i zmniejsza nasilenie objawów naczynioruchowych związanych z menopauzą.
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E.2.2 | Secondary objectives of the trial |
Demonstration that DHEA supplementation in a dose of 35 mg affects the concentration of DHEA and estradiol. |
Wykazanie, że suplementacja DHEA w dawce 35 mg wpływa na stężenie DHEA i estradiolu. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
kobieta, BMI 20,0-29,9 kg/m2, czas od ostatniej miesiączki co najmniej 12 miesięcy, stabilna masa ciała w czasie ostatnich 6 miesięcy, stężenie FSH 35-135 mIU/ml i estradiol 5-55 pg/ml, stężenie testosteronu całkowitego 0,084 - 0,481 ng/ml, wynik w skali depresji Becka 11–27 punktów, wynik w Skala Kuppermana 17-30 punktów, deklarowana aktywność seksualna, skala FSFI nie stosowanie menopauzalnej terapii zastępczej od co najmniej 6 miesięcy, umiejętność zrozumienia procedur badania i udzielenie pisemnej świadomej zgody.
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E.4 | Principal 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 |
Aktualne stosowanie menopauzalnej terapii zastępczej, Stosowanie fitoestrogenów, Stosowanie leków psychotropowych, Stosowanie glikokortykosteroidów doustnie lub dożylnie, Dopochwowe stosowanie DHEA (Prasteron), Choroba onkologiczna obecnie lub w wywiadzie, Niewyrównana choroba tarczycy lub inna choroba endokrynna, np. zespół Cushinga, Niekontrolowane choroby sercowo-naczyniowe (nadciśnienie tętnicze, choroba wieńcowa, niewydolność serca), Choroba zwyrodnieniowa stawów ze znacznymi dolegliwościami bólowymi z zastosowaniem sterydoterapii, Reumatoidalne zapalenie stawów i inna choroba reumatologiczna z zastosowaniem sterydoterapii, Choroba układu nerwowego mogąca wpływać na jakość życia, Choroba psychiczna w wywiadzie (oprócz depresji pomenopauzalnej), Brak współpracy pacjentki
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E.5 End points |
E.5.1 | 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. |
Wykazanie, że 12 tygodniowa suplementacja DHEA w dawce 35 mg poprawia jakość życia seksualnego i zmniejsza objawy atrofii pochwy. Wykazanie, że suplementacja DHEA w dawce 35 mg poprawia nastrój i zmniejsza nasilenie objawów naczynioruchowych związanych z menopauzą. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Demonstration that 35 mg DHEA supplementation affects serum levels of LH, DHEAS and estradiol |
Wykazanie, że suplementacja DHEA w dawce 35 mg wpływa na stężenia w surowicy LH, DHEAS i estradiolu. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |