Postmenopausal estrogen replacement regimen is the therapy of choice for the alleviation of climacteric symptoms. During the past few years, continuous-combined hormone replacement therapy (HRT) have become increasingly popular. Lower dose estrogen-progestogen combinations are likely to induce less bleeding disturbances and other adverse effects (AEs) and may therefore improve compliance and allow long-term treatment, necessary, e.g. for the prevention of postmenopausal bone loss. MedDRA vers
Conditions
Interventions
Trade Name: Indivina 1.0 mg/ 2.5 mg
Indivina 1.0 mg/ 5.0 mg
Indivina 2.0 mg/ 5.0 mg
Product Name: Indivina
Pharmaceutical Form: Tablet
Concentration unit: IU/mg international unit(s)/milligram
Con
Sponsors
Orion Corporation, Orion Pharma, Orionintie,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • signed and dated IC • Postmenopausal women: = 12 months of spontaneous amenorrhoea or = 6 weeks post-surgical bilateral oophorectomy without hysterectomy at screening • = 30 moderate to severe hot flushes per week at baseline and/or vasomotor symptoms requiring treatment according to clinical judgement of the investigator • Wash-out period - is not needed or - of 1 wk or longer for prior vaginal hormonal products (rings, creams, gels) - of 4 wks or longer for prior transdermal estrogen alone or estrogen/progestin products - of 4 wks or longer for prior oral estrogen and/or estrogen/progestin therapy - of 8 wks or longer for prior intrauterine progestin therapy - of 3 months or longer for prior progestin implants and estrogen alone injectable drug therapy - of 6 months or longer for prior estrogen pellet therapy or progestin injectable drug therapy • no pathological findings in mammogram obtained within 6 months of screening visit 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 36 months of spontaneous amenorrhea at screening • pregnancy or breastfeeding • known or past endometrial hyperplasia or cancer • known, past, or suspected estrogen-dependent malignant tumours (e.g. breast cancer) • cervical smear class III-IV according to the Bethesda classification • undiagnosed uterine bleedings • previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) • active or recent arterial thromboembolic disease (e.g. angina pectoris, myocardial infarction) • personal or strong family history of thromboembolism or recurrent (= 3) spontaneous abortions • heart failure (NYHA class III-IV) • cerebrovascular accidents, stroke or transient ischemic attacks in the subject history • serious disorders of blood coagulation system • acute liver disease or a history of liver disease (including cholelithiasis) with clinically significant abnormalities in liver function tests at baseline • porphyria • uterine fibroids • endometriosis • known hypersensitivity to any component of the preparations • uncontrolled or poorly controlled hypertension (diastolic BP > 95 mmHg and/or systolic BP > 160 mmHg) despite of antihypertensive treatment • severe or uncontrolled thyroid disease, e.g. thyreotoxicosis • impaired renal function with clinically significant elevated serum creatinine concentration • insulin-dependent diabetes mellitus • diagnosed psychiatric disorders (e.g. schizophrenia, depression) • systemic lupus erythematosus (SLE) • any other treatment for climacteric symptoms • any treatment for hyperlipidemias • any treatment affecting sex hormone system (e.g. phytoestrogens like soya) • suspected alcohol or drug abuse • suspected poor compliance • participation in another clinical study within the previous 60 days or during the study • clinically significant abnormalities in the laboratory assessments at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate efficacy and safety of 3 continuous combined regimens of Indivina in alleviation of vasomotor (estrogen deficiency) symptoms in women who are more than 1 year menopausal, by measuring the change in frequency and severity of moderate to severe vasomotor symptoms from baseline to Week 12 vasomotor (estrogen deficiency) symptoms using a self-assessed symptoms diary.;Secondary Objective: The secondary objectives include investigations of bleeding days, vasomotor symptoms, alleviation of other estrogen deficiency symptoms, and quality of life (QoL). ;Primary end point(s): The change in frequency and severity of moderate to severe vasomotor symptoms from baseline to Week 12 vasomotor (estrogen deficiency) symptoms using a self-assessed symptoms diary. | — |
Countries
Czech Republic
Outcome results
None listed