Vasomotor symptoms MedDRA version: 20.0 Level: LLT Classification code 10020407 Term: Hot flashes System Organ Class: 100000004866
Conditions
Sponsors
Besins Healthcare Ireland Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in the screening period of this study must satisfy all the following criteria: 1. Willing and able to provide written informed consent 2. Adult (= 18 years), postmenopausal women, where postmenopause is defined as a. at least 12 months of spontaneous amenorrhea, or b. 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) levels > 40 mIU/ml, or c. status at least 6 weeks after bilateral oophorectomy with or without hysterectomy, or d. subject post hysterectomy without oophorectomy with documented FSH level > 40 mIU/ml and estradiol level =65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: 1. Use of any hormone replacement therapy (including phytoestrogens and other plant-derived sex hormones) within 12 weeks prior to screening 2. Endometrial thickness = 5 mm at screening visit 3. Any history or current presence or suspicion of breast cancer, including carcinoma in situ and other pre-cancerous conditions 4. Active malignant disease of any organ system (except for localized basal cell carcinoma of the skin) or history thereof in the last 5 years prior to screening visit 5. Vaginal bleeding due to unidentified reason within 6 weeks prior to screening 6. Ongoing venous thromboembolic event or history thereof within 12 months prior to screening visit 7. Known severe renal insufficiency at screening visit 8. Known lipid metabolism disturbances of genetic origin (e.g. familial hypercholesterolemia, familial hypertriglyceridemia) 9. Acute or chronic liver diseases or a history of liver disease with liver enzymes having not normalized since then 10. Severe disturbances of hepatic function (including porphyria), hepatic tumors, also in medical history 11. Rotor syndrome or Dubin-Johnson syndrome 12. History of icterus or generalized pruritus during a previous pregnancy 13. History of myocardial infarction, stroke or transient ischemic attack or severe cardiac disease, including symptomatic chronic heart failure 14. Ongoing major depression 15. Use of SSRI, SNRI for any reason within 6 weeks prior to screening or planned use during the course of the study 16. Acupuncture for VMS within 2 weeks prior to screening or planned during the course of the study 17. Diabetes mellitus 18. Hypersensitivity to progesterone or excipients (e.g. soy) of the study medication 19. Medical history of HIV infection 20. Concomitant diseases or therapies that may cause VMS or affect VMS frequency or severity, e.g. but not limited to poorly controlled thyroid dysfunction (thyroid medication should be stable for at least 12 weeks prior to screening and TSH levels should be within range), fear disorders (e.g. panic disorders) 21. Participation in a clinical trial or intake of any investigational medicinal product within three months prior to screening visit 22. Previous participation in this clinical trial 23. Known or suspected drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in postmenopausal women. ;Primary end point(s): The primary endpoint of the study is the change vs. baseline of the daily frequency of moderate or severe VMS episodes after 12 weeks of treatment with micronized progesterone or placebo. ;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment; Secondary Objective: The key secondary objectives of the study are • to show that BHR-401 treatment is more effective than placebo in reducing VMS severity at week 12. • to show that BHR-401 treatment is more effective than placebo in reducing VMS frequency and severity at treatment week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints are • Change vs. baseline of VMS severity after 12 weeks of treatment • Change vs. baseline of the daily frequency of moderate or severe VMS episodes after 4 weeks of treatment • Change vs. baseline of VMS severity after 4 weeks of treatment Further secondary endpoints include • Incidence of adverse events (AEs) and serious adverse events (SAEs) • Change vs. baseline of postmenopausal symptoms as assessed by the subjects by means of the MRS after 4 weeks and 12 weeks of treatment • Change in subjective sleep quality vs. baseline as assessed by means of the Pittsburgh Sleep Quality Index (PSQI) after 4 weeks and 12 weeks of treatment ;Timepoint(s) of evaluation of this end point: After 4 and after 12 weeks of treatment | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactClinical Trials Project Management
GKM Gesellschaft für Therapieforschung mbH
Outcome results
None listed