Status:
TERMINATED
A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Lead Sponsor:
Maire Mac Bride
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Atrophic Vaginitis
Eligibility:
FEMALE
40-75 years
Phase:
PHASE3
Brief Summary
Atrophic vaginitis is a common problem that occurs in up to 40% of postmenopausal women. The main symptoms are dryness, itching and burning in and around the vagina. These symptoms in turn can cause p...
Detailed Description
This trial will measure the effects of very low doses of estradiol or estriol cream applied to the vaginal introitus for the treatment of atrophic vaginitis, a common condition affecting up to 40% of ...
Eligibility Criteria
Inclusion
- Postmenopausal women (no menses for the previous 12 months)
- Dryness, itching or burning in and around the vagina
- Discontinued hormone replacement therapy (either local or systemic) at least 3 months
Exclusion
- Known, suspected, or history of cancer of the breast.
- Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).
- Known hypersensitivity to any component of the medications or base creams.
- Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
- Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).
- Liver dysfunction or disease with elevation of aspartate aminotransferase (AST)\>1.5x upper level of normal (ULN); Normal for females is 8-43 U/L.
- Undiagnosed abnormal genital bleeding.
- Known chronic lichen sclerosis.
- Known, untreated vaginal infection.
- Not had a normal screening mammogram within the last 15 months.
- Hysterectomy without oophorectomy unless 60 years or older.
- Women taking aromatase inhibitors or tamoxifen.
- Hgb \<12.0 or \>15.5 g/dL
- Urinalysis showing a urinary tract infection (UTI).
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00816556
Start Date
October 1 2008
End Date
December 1 2011
Last Update
November 13 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905