Phase 2
N=87
Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT05419908 ↗Enrolled (actual)
87
Serious AEs
1.2%
Results posted
Jul 2023
Primary outcome: Primary: Change From Baseline to Week 12 in The Weekly General Hot Flash Score — -12.19; -26.51 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fezolinetant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Ogeda S.A.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in The Weekly General Hot Flash Score |
-12.19; -26.51 | <0.001 sig |
| SECONDARY Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1) |
-0.294; -1.428; -0.608; -1.557; -0.534; -1.656 | <0.001 sig |
| SECONDARY Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2) |
-9.55; -25.26; -11.91; -25.71; -12.14; -26.61 | <0.001 sig |
| SECONDARY Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12 |
-26.4; -72.3; -32.9; -73.3; -35.6; -75.3 | <0.001 sig |
| SECONDARY Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 |
22.7; 87.8; 39.0; 87.5; 42.5; 95.0 | <0.001 sig |
| SECONDARY Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 |
9.1; 78.0; 26.8; 77.5; 30.0; 87.5 | <0.001 sig |
| SECONDARY Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12 |
6.8; 61.0; 12.2; 60.0; 15.0; 62.5 | <0.001 sig |
| SECONDARY Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 |
45.5; 95.1; 53.7; 97.5; 55.0; 97.5 | <0.001 sig |
| SECONDARY Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 |
25.0; 87.8; 46.3; 92.5; 40.0; 97.5 | <0.001 sig |
| SECONDARY Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12 |
6.8; 68.3; 24.4; 67.5; 20.0; 72.5 | <0.001 sig |
| SECONDARY Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12 |
-1.7; -4.6; -2.4; -5.0; -2.3; -4.6 | <0.001 sig |
| SECONDARY Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12 |
1.017; 2.283; 1.145; 2.248; 1.282; 2.094 | <0.001 sig |
| SECONDARY Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8 and 12 |
-0.4; -0.5; -0.5; -0.7; -0.4; -0.6 | 0.881 |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 |
-1.3; -3.6; -1.7; -4.4; -1.8; -4.3 | <0.001 sig |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) at Weeks 4, 8 and 12 (Days Lost and Days Unproductive) |
-0.2; 0.0; -0.3; 0.0; -0.2; 0.0 | 0.936 |
| SECONDARY Change From Baseline in Plasma Concentration of Luteinizing Hormone (LH) |
-2.34; -8.84; -3.86; -9.46; -4.61; -9.72 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Follicle-Stimulating Hormone (FSH) |
-5.80; -3.44; -6.60; -10.36; -7.05; -10.51 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Estradiol (E2) |
18.4; -7.3; 26.0; 1.0; 32.3; 25.5 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Sex Hormone-Binding Globulin (SHBG) |
0.61; -0.47; 5.10; -1.37; 1.75; 0.36 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Leptin |
1.2436; -2.2185; 1.6225; -1.7090; 0.9668; -0.4183 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Insulin |
-0.2767; -0.7512; 0.3525; -0.5325; -0.0825; 0.1300 | — |
| SECONDARY Change From Baseline in Plasma Concentration of C-peptide |
-0.0465; -0.1463; -0.0300; -0.1175; -0.0750; -0.0425 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Glycated Hemoglobin (HBA1c) |
-0.00050000; -0.002307692 | — |
| SECONDARY Number of Participants With Adverse Events (AE's) |
35; 29; 1; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Bone Alkaline Phosphatase (BALP) at Week 12 |
2.9; 1.7 | — |
| SECONDARY Change From Baseline in Plasma Concentration of Carboxy-terminal Telopeptide of Type I Collagen (CTX) at Week 12 |
-0.021; 0.001 | — |
Summary
The primary purpose of this study was 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.
This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes at additional timepoints; hot flash interference on daily life, in terms of changes from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale (SDS); pharmacodynamic (PD) effect; and safety and tolerability.
Eligibility Criteria
Inclusion Criteria
- 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 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;
- 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;
- 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;
- Unsuited to participate in the study, based on findings observed during physical examination, vital sign assessment, or 12-lead ECG;
- History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients;
- Presence or sequellae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion (ADME) mechanisms of drugs;
- Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study);
- History of poor compliance in clinical studies;
- Unable or unwilling to complete the study procedures;
- 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.
Data sourced from ClinicalTrials.gov (NCT05419908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.