In vivo effects of transdermal Estradiol+ oral Progesterone vs oral Conjugated Equine Estrogens + MedroxyProgesteroneAcetate on normal human breast cells proliferation: a randomized comparative study

• Conditions: Menopausal symptoms

• Registration Number: EUCTR2005-001016-51-SE
• Lead Sponsor: Karolinska Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 80

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

-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 < 18,1 or >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified