Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
1 year
Yes
Boris Kaplan, prof
Principal Investigator
Rabin Medical Center Beilinson Hospital
Israel: Ministry of Health
fr003
NCT00919919
June 2009
November 2010
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