hot flashes MedDRA version: 18.1 Level: LLT Classification code 10020407 Term: Hot flashes System Organ Class: 100000004866
Conditions
Interventions
Product Code: ESN-364
Pharmaceutical Form: Capsule, hard
CAS Number: not assigned
Current Sponsor code: ESN-364
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Sponsors
Euroscreen S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women, between 40 and 65 years old (extremes included) at screening; 2. Spontaneous amenorrhea for at least 12 consecutive months; or spontaneous amenorrhea for at least 6 months with biochemical criteria of menopause (FSH >40 IU/L); or spontaneous amenorrhea for at least 3 months with biochemical/physical criteria of menopause (FSH >40 IU/L and E2 =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Use of a prohibited therapy or not willing to wash-out drugs as mentioned in the prohibited therapies section (Section 6.2); 2. History (in the past year) or presence of drug or alcohol abuse; 3. Suicide attempt in the past 3 years; 4. Previous or current history of a malignant tumor (except basal cell carcinoma); 5. Active liver disease or jaundice, or out-of-range values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST); or total bilirubin >1.3 times the upper limit of normal (ULN); or creatinine >1.5 times the ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula <60 mL/min/1.73 m2 at screening; 6. Medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], or endocrine disease) or malignancy that could confound interpretation of the study outcome, as judged by the Investigator; 7. Any psychological disorder according to the criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders (DSM, 4th edition) within one year prior to screening. Such disorders include but are not limited to current major depression, alcohol (more than 3 glasses of wine, beer, or equivalent/day) or substance abuse/dependence; 8. Judged by the Investigator to be unsuited to participate in the study, based on findings observed during physical examination, vital sign assessment, or 12-lead ECG; 9. History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients; 10. Presence or sequellae of gastrointestinal, liver, kidney or other conditions known to interfere with the ADME mechanisms of drugs, as judged by the Investigator; 11. Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study); 12. History of poor compliance in clinical studies; 13. Unable or unwilling to complete the study procedures; 14. Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of ESN364 on the severity and frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot Flash Score from baseline to Week 12.;Primary end point(s): Pharmacokinetics: Assessment of plasma ESN364 concentrations will be exploratory. Efficacy: Change from baseline to Week 12 in weekly Hot Flash Score;Timepoint(s) of evaluation of this end point: during the trial;Secondary Objective: -effect of ESN364 on the frequency of hot flashes, in terms of changes in weekly Hot Flash Frequency from baseline to Week 12; -effect of ESN364 on the severity and frequency of hot flashes in terms of changes in weekly Hot Flash Score and Hot Flash Frequency and severity from baseline to Weeks 4 and 8, and at fu; -effect of 12-week administration of ESN364 on hot flash interference on daily life in terms of changes from baseline over time in HFRDIS; -effect of 12-week administration of ESN364 on climacteric symptoms in terms of changes from baseline over time in LSEQ, GCS, and SDS; -effect of 12-week administration of ESN364 on body composition assessed by DEXA; -effect of 12-week administration of ESN364 on sex hormone plasma conc and SHBG; -effect of 12-week administration of ESN364 on exploratory hormone plasma conc. -safety and tolerability of 12-w administration of ESN364 in terms of AEs, physical examination, vital signs, ECG, clinical laboratory safety, and BALP conc. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: during the trial;Secondary end point(s): Efficacy: Secondary endpoints: - Changes from baseline over time in weekly Hot Flash Score and Hot Flash Frequency; - Change from baseline over time in HFRDIS score; - Changes from baseline over time in LSEQ, GCS, and SDS. Exploratory endpoint: the change from baseline to Week 12 in body composition (lean mass, fat mass, bone mass/density) will be explored Pharmacokinetics: Assessment of plasma ESN364 concentrations will be exploratory. Pharmacodynamics: Changes in plasma concentrations of LH, FSH, E2, SHBG, leptin, insulin, C-peptide, and HBA1c from baseline over time will be evaluated. Safety - AE frequency and severity from first dose of study drug through the last visit; - Changes from baseline over time in hematology and biochemistry concentrations; - Changes from baseline over time in vital sign and ECG assessments; - Changes from baseline over time in BALP and CTX levels. | — |
Countries
Belgium
Contacts
Public ContactSteven Ramael
Euroscreen S.A
Outcome results
None listed