Menopausal symptoms
Conditions
Interventions
Trade Name: Utrogestan
Product Name: Utrogestan
Pharmaceutical Form: Tablet
Trade Name: Oestrogel
Product Name: Oestrogel
Pharmaceutical Form: Gel
Trade Name: Premelle Cycle
Product Name: Premelle C
Sponsors
Karolinska Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 80 healthy, non-smoking postmenopausal women, between 40 and 65 years of age, without known breast pathology. Normal screening mammogram. 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: -known malignant breast pathology -multiple scars on breasts after breast surgery -current treatment of following medications: any hormonal replacement therapy; three months wash out period for past users any long term treatment containing progestin or estrogen any drugs known to inhibit hepatic drug metabolism ( i.e. barbiturates, carbamazepines, phenytoin, glucocorticoids, rifampin, antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, verapamil, quinidine ) -participation in an investigational study within 30 days prior to the study medication -any clinically significant abnormality found during medical screening -any clinically significant abnormal laboratory test -BMI 29,9 -history of allergic reactions to the IMP´s -history of severe liver or gallbladder disease or dysfunction, coagulation disorder -History of active malignancy. -Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study. -Subjects will be instructed to abstain from vitamins, alcohol, tobacco and natural products starting 7 days prior to study treatment until the end of the study. Precise information will be recorded in the clinical forms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to investigate the potential differences between the effects on breast cell proliferation of natural progesterone combined with percutanous estrogen versus a combination of oral conjugated equine estrogens (CEE) + medroxyprogesterone acetate (MPA). Therefore, to confirm or refute whether these different types of combined HRT have different in vivo effects in the short term on proliferation and apoptosis in breast cells from normal postmenopausal women. 80 patients, 40 in each group, are randomized to either of treatments. Every woman is her own control. Medium needle biopsy is performed before and after 2 months of treatment and markers for proliferation, apoptosis as well as estrogen- and progesterone receptors are analyzed. ;Secondary Objective: -To compare the nuclear intensity of estadiol (ER alfa and ER beta) and progesterone receptors (PR A and PR B) in fixed normal breast tissue. -To evaluate tissue concentrations of estradiol, estrone, estrone sulphate, progesterone and MPA in frozen mammary gland tissue. -To evaluate plasma concentrations of estradiol, estrone, progesterone, MPA testosterone, free testosterone and SHBG at the time of the needle aspiration. -To evaluate eventual change in mammographic breast density. -To evaluate vascularization with anti-VEGF antibody in fixed tissue.;Primary end point(s): To define breast cell turn-over (proliferation markers: PCNA, Ki67 apoptosis markers: Bcl-2 and caspase-3) during the two different treatments. | — |
Countries
Sweden
Outcome results
None listed