Status:
UNKNOWN
Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Endometrial Hyperplasia
Endometrial Cancer
Eligibility:
FEMALE
45-60 years
Phase:
PHASE2
Brief 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 preven...
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.
Eligibility Criteria
Inclusion
- 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
- Submucosal fibroid/s that applying pressure and affecting endometrial thickness
- Other medication that could affect estrogenic state.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00919919
Start Date
June 1 2009
End Date
November 1 2010
Last Update
June 12 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rabin Medical Center Beilinson Hospital
Petah Tikva, Israel