Status:
COMPLETED
Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen
Lead Sponsor:
Eli Lilly and Company
Conditions:
Vasomotor Symptoms
Endometrial Safety
Eligibility:
FEMALE
50-70 years
Phase:
PHASE2
Brief Summary
This pilot study was designed to explore the effects of combined treatment with raloxifene HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes plus night swea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00332553
Start Date
February 1 2002
End Date
May 1 2004
Last Update
May 15 2007
Active Locations (1)
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1
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, United States