The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
Rabin Medical Center Beilinson Hospital
Petah Tikva, Israel
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
Time frame: 1 year
Comparison of the proportion of bleeding pattern between the two groups.
Time frame: 1 year
To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.
Time frame: 1 year
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