NCT00919919

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Endometrial Hyperplasia
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	progesterone	Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
DRUG	activella	Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2009-06-12
• Last updated: 2009-06-12

Locations

1 site across 1 country: Israel