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Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen


Phase 2
50 Years
70 Years
Not Enrolling
Female
Vasomotor Symptoms, Endometrial Safety

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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