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

• Status: Unknown status
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: Ferring Pharmaceuticals
• Treatments: Estradiol; Estrogens; Norethindrone acetate; Progesterone

Criteria

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.