Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen

Completed · Phase 2

Conditions studied: Vasomotor Symptoms, Endometrial Safety

In brief

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 sweats) in postmenopausal women discontinuing continuous combined hormone replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.

Key facts

Study ID

NCT00332553

Run by

Eli Lilly and Company

People needed

150

Starts

2002-02-01

Expected to finish

2004-05-01

Last updated by the study team

2007-05-15

Who can join

Age: 50 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.