Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen
Phase 2
50 Years
70 Years
50 Years
70 Years
Not Enrolling
Female
Vasomotor Symptoms, Endometrial Safety
Female
Vasomotor Symptoms, Endometrial Safety
Trial Information
Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen
Inclusion Criteria:
- Post menopausal women, 50-70 years of age
- Had taken ccHRT for at least 6 months prior to study entry
- No unexplained vaginal bleeding in the 3 months prior to study entry
- Understand and sign an informed consent document
Exclusion Criteria:
- Prior hysterectomy
- Endometrial thickness (excluding endometrial fluid) greater than 8 mm or endometrial
fluid greater than or equal to 4 mm at study entry
- Abnormal Pap smear at study screening or within the preceding 3 years
- Abnormal transvaginal ultrasound result at study screening
- Past or current history of malignant neoplasms
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
Compare the number of vasomotor symptoms at 12 weeks between those women taking the combination of raloxifene with oral estradiol versus those taking raloxifene alone.
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
5546
NCT ID:
NCT00332553
Start Date:
February 2002
Completion Date:
May 2004
Related Keywords:
- Vasomotor Symptoms
- Endometrial Safety
- Adenoma
Name | Location |
|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877- CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Indianapolis, Indiana |
