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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-004160-16
    Sponsor's Protocol Code Number:PBKV.8zdnia01.06.2022
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-11-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-004160-16
    A.3Full title of the trial
    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.
    Randomizowane, podwójnie zaślepione, kontrolowane placebo wieloośrodkowe badanie oceny wpływu 12-tygodniowego stosowania połączenia DHEA w dawce 20 mg i 2 mg melatoniny o przedłużonym uwalnianiu na jakość snu i nastrój u kobiet pomenopauzalnych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    Randomizowane, podwójnie zaślepione, kontrolowane placebo wieloośrodkowe badanie oceny wpływu 12-tygodniowego stosowania połączenia DHEA w dawce 20 mg i 2 mg melatoniny o przedłużonym uwalnianiu na jakość snu i nastrój u kobiet pomenopauzalnych.
    A.3.2Name or abbreviated title of the trial where available
    DHM/EPH/01/2022
    A.4.1Sponsor's protocol code numberPBKV.8zdnia01.06.2022
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe Pharmaceutical Company LEK-AM Sp. Zoo.
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportN/A
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropharma M. Rachtan Sp. z o.o.
    B.5.2Functional name of contact pointCRO Clinical Trial
    B.5.3 Address:
    B.5.3.1Street AddressKrzywa 6
    B.5.3.2Town/ cityKatowice
    B.5.3.3Post code40-061
    B.5.3.4CountryPoland
    B.5.6E-maileuropharma@europharma.edu.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Biosteron 10 mg, Senaxa PR
    D.2.1.1.2Name of the Marketing Authorisation holderThe Pharmaceutical Company LEK-AM Sp. z o.o.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDHEA and Melatonin
    D.3.2Product code PR1-777-2022, PR2-777-2022
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Menopause, sleep disorders in the postmenopausal period
    Menopauza, zaburzenia snu w okresie pomenopauzalnym
    E.1.1.1Medical condition in easily understood language
    Menopause, sleep disorders in the postmenopausal period
    Menopauza, zaburzenia snu w okresie pomenopauzalnym
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstration that 12-week supplementation with 20 mg DHEA and 2 mg sustained-release melatonin improves sleep quality and reduces daytime sleepiness.
    Demonstration that supplementation with 20 mg DHEA and 2 mg sustained-release melatonin improves mood and reduces the severity of vasomotor symptoms associated with menopause.
    Wykazanie, że 12-tygodniowa suplementacja DHEA w dawce 20 mg i 2 mg melatoniny o przedłużonym uwalnianiu poprawia jakość snu i zmniejsza nasilenie senności w czasie dnia.
    Wykazanie, że suplementacja DHEA w dawce 20 mg i 2 mg melatoniny o przedłużonym uwalnianiu poprawia nastrój i zmniejsza nasilenie objawów naczynioruchowych związanych z menopauzą.
    E.2.2Secondary objectives of the trial
    Demonstration that DHEA supplementation at a dose of 20 mg and 2 mg of sustained-release melatonin affects the concentration of DHEAS and estradiol.
    Wykazanie, że suplementacja DHEA w dawce 20 mg i 2 mg melatoniny o przedłużonym uwalnianiu wpływa na stężenie DHEAS i estradiolu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - woman,
    - BMI 20.0-29.9 kg / m2,
    - the time since the last menstruation for at least 12 months,
    - stable body weight during the last 6 months,
    - FSH concentration 35-135 mIU / ml and estradiol 5-55 pg / ml,
    - total testosterone concentration 0.084 - 0.481 ng / ml,
    - score on the Athens Insomnia Scale> 6 points,
    - Beck Depression Score 11–27 points,
    - Kupperman Scale score 17-30 points,
    - Epworth scale score
    - no use of 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 od 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 Ateńskiej Skali Bezsenności > 6 punktów,
    - wynik w skali depresji Becka 11–27 punktów,
    - wynik w Skala Kuppermana 17-30 punktów,
    - wynik skali Epworth
    - nie stosowanie menopauzalnej terapii zastępczej od co najmniej 6 miesięcy
    - umiejętność zrozumienia procedur badania i udzielenie pisemnej świadomej zgody.

    E.4Principal exclusion criteria
    - Current use of menopausal replacement therapy,
    - The use of phytoestrogens,
    - The use of psychotropic drugs,
    - Taking sleeping pills,
    - 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
    - Diagnosed obstructive sleep apnea,
    - 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 sleep disturbances,
    - History of mental illness (except postmenopausal depression),
    - The patient's lack of cooperation.
    - Aktualne stosowanie menopauzalnej terapii zastępczej,
    - Stosowanie fitoestrogenów,
    - Stosowanie leków psychotropowych,
    - Stosowanie leków nasennych,
    - 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,
    - Rozpoznany obturacyjny bezdech senny,
    - 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 zaburzenia snu,
    - Choroba psychiczna w wywiadzie (oprócz depresji pomenopauzalnej),
    - Brak współpracy pacjentki.
    E.5 End points
    E.5.1Primary end point(s)
    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.
    Pierwszorzędowymi punktami końcowymi tego badania są: ocena wpływu 12-tygodniowego stosowania DHEA w dawce 20 mg i 2 mg melatoniny o przedłużonym uwalnianiu - na jakość snu kobiet pomenopauzalnych oraz nastrój i zmniejszenie objawy naczynioruchowych związanych z menopauzą.
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    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.
    Ocena wpływu 12-tygodniowego stosowania DHEA w dawce 20 mg i 2 mg melatoniny o przedłużonym uwalnianiu na stężenie w surowicy DHEAS, estradiolu, LH i SHBG
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N/A
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2024-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-03
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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