Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study

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.

Inclusion Criteria:

• Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
• Women with an intact uterus.
• No menses within the 12 months preceding screening visit and /or FSH >30 IU/L.
• Endometrial thickness ≤ 5 mm.

Exclusion Criteria:

• Submucosal fibroid/s that applying pressure and affecting endometrial thickness
• Other medication that could affect estrogenic state.