menopausal hot flushes MedDRA version: 18.0 Level: LLT Classification code 10027311 Term: Menopause flushing System Organ Class: 100000004872
Conditions
Interventions
Product Code: AZD4901
Pharmaceutical Form: Film-coated tablet
CAS Number: 941690-55-7
Current Sponsor code: AZD4901
Other descriptive na
Sponsors
Imperial College, Joint Research Compliance Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Menopausal women (=12 months since last menstrual period or bilateral oophorectomy or with an FSH level =20 mIU/mL and an estradiol level 7HF/day some of which are reported as severe or bothersome who have not been on treatment for menopausal symptoms for the preceding 8 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Significant illness, as judged by the Investigator, within 2 weeks of first study visit. 2.Volunteer has clinical, laboratory, or ECG evidence of uncontrolled hypertension (defined as systolic blood pressure of = 160 mmHg and/or diastolic blood pressure of =100 mmHg); uncontrolled diabetes; or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator. 3.Patient has a history of Gilbert's syndrome, infectious hepatitis, or other significant hepatic disease (e.g. chronic hepatitis, cirrhosis, autoimmune hepatitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis, or hereditary liver disease) in the opinion of the Investigator. 4.Patient has a history of surgery which in the opinion of the investigator could cause malabsorption (e.g. gastric or small intestinal surgery or gastric bypass surgery or banding), or patient has a disease that causes malabsorption. 5.Clinically significant abnormal ECG and/or abnormalities in ECG at screening as judged by the Investigator. 6.A marked prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 450 ms). 7.Confirmed history of ischaemic heart disease. 8.Past (within 1 year of enrolment) or present alcohol or substance abuse 9.Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 3 months of the first administration of AZD4901 in this study. The period of exclusion begins 3 months after the final dose. (Note: patients consented and screened, but not randomised in a previous study are not excluded.) 10.Patient has a history of neoplastic disease within 5 years prior to signing informed consent or is currently on ongoing treatment to prevent cancer recurrence. 11.Involvement in the planning and/or conduct of the study (applies to any AstraZeneca employee and their close relatives and/or staff at the study site directly involved in the study, regardless of their role in accordance with their internal procedures) 12.Inability to understand or cooperate with the requirements of the study 13.Patient is legally or mentally incapacitated 14.Patient has significant psychiatric disease or treatment for psychiatric disease e.g. SSRI’s which in the opinion of the Investigator may influence the results of the study. 15.Patient has abnormal screening laboratory values as per the guidelines listed below or other clinically significant, unexplained laboratory abnormality according to the Investigator: -Aspartate aminotransferase (AST) >1.5 times ULN -Alanine aminotransferase (ALT) > 1.5 times ULN -Total bilirubin >1.5 times ULN -Serum creatinine >2.0 times ULN 16.Clinically relevant disease and abnormalities (past or present), which in the opinion of the Investigator, may either put the patient at risk to participate in this study or may influence the results of the study or the patient’s ability to participate in the study. 17.Patient has a history of hyperthyroidism or hypothyroidism or abnormal screening thyroid tests,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if AZD4901 is effective in reducing the frequency of menopausal hot flushes by mean Hot Flush (HF) frequency per day (HF/day). ; Secondary Objective: average mean HF frequency HF severity HF bother HF interference A general menopausal symptom scale score (MENQOL questionnaire, Hilditch 1996) will be recorded daily on waking Skin conductance monitor data. Modified Medication Adherence Questionnaire to assess compliance (Morisky 1986) will be recorded twice daily. Gonadotrophins & Oestradiol. Blood will be taken at each weekly visit throughout entire study period to measure gonadotrophins & Oestradiol. Mean LH ±FSH during 8h blood sampling studies. These visits will be voluntary and subject to patient’s consent and availability ;Primary end point(s): Mean HF frequency per day (HF/day). ;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): average mean HF frequency HF severity HF bother HF interference A general menopausal symptom scale score (MENQOL questionnaire, Hilditch 1996) will be recorded daily on waking Skin conductance monitor data. Modified Medication Adherence Questionnaire to assess compliance (Morisky 1986) will be recorded twice daily. Gonadotrophins & Oestradiol. Blood will be taken at each weekly visit throughout entire study period to measure gonadotrophins & Oestradiol. Mean LH ±FSH during 8h blood sampling studies. These visits will be voluntary and subject to patient’s consent and availability ;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
United Kingdom
Contacts
Public ContactResearch Governance Manager
Imperial College London
Outcome results
None listed