Climacteric symptoms
Conditions
Interventions
Trade Name: Utrogestan
Product Name: Micronized progesterone
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Acti
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH > 40 IE/L) with climacteric symptoms (sweating, hot flush and sleep problems) that adversely affect quality of life. - Age 45-60 years - BMI > 19 kg/m2 and = 32 kg/m2 - Intact uterus - In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local estrogen treatment before screening - Written informed consent 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 520 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous history of breast cancer or abnormal mammogram at baseline as assessed clinically by a radiology expert - Previous history of endometrial cancer or hyperplasia or abnormal/proliferative endometrial biopsy at baseline - Vaginal bleeding - Any concomitant medical treatment except for well-controlled hypertension, non-insulin treated type 2 diabetes, asthma and hypothyroidism - History or presence of cardiovascular disease including thromboembolic disorder or cerebrovascular disease - History or presence of liver disease, familial hyperlipidemia, epilepsy or classical migraine with aura - History or presence of clinically significant depression or other psychiatric disorder that might in anyway compromise the performance of the trial or undermine its scientific validity - Current use of MHT or local estrogen treatment - Alcohol and/or drug abuse - Clinically significant findings on physical and/or gynecological examination at baseline - Hypersensitivity to any of the study treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of one-year treatment with mP versus NETA, both in combination with estradiol, on mammographic breast density.;Secondary Objective: To compare the effects of one-year treatment with mP versus NETA, both in combination with estradiol, on the secondary outcomes below: - Breast cell proliferation - Endometrial cell proliferation - Endometrial thickness using ultrasound - Bleeding pattern Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue - Depression and anxiety symptoms (PHQ-9, HADS) - Health-related quality of life (PGWB) - Women’s Health Questionnaire (WHQ) - Blood lipid profile, serum hormones, growth and metabolic factors ;Primary end point(s): -Percentage change in mammographic density compared between the groups.;Timepoint(s) of evaluation of this end point: After 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of endometrial proliferation (proliferation marker (Ki67) - Endometrial thickness on ultrasound - Bleeding pattern as documented in a bleeding diary - Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue - Depression and anxiety symptoms (Patient Health Questionnaire (PHQ-9), Hospital Anxiety and Depression Scale (HADS)) - Health-related quality of life (Psychological General Well-Being Index (PGWB)) - Women’s Health Questionnaire (WHQ) - Blood lipid profile, serum hormones, growth and metabolic factors (follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, sex hormone-binding globulin, IGF–I and its binding proteins). Incidence of endometrial hyperplasia and cancer. ;Timepoint(s) of evaluation of this end point: After 12 months of treatment | — |
Countries
Sweden
Contacts
Public ContactClinical Research Unit
Karolinska University Hospital
Outcome results
None listed