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

Phase 2

Completed

• Conditions: Vasomotor Symptoms; Endometrial Safety

• Registration Number: NCT00332553
• Lead Sponsor: Eli Lilly and Company

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study Completion: 2004-05
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-06-01
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-11
• Last Update Posted: 2007-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Determine the effect of treatment with combined raloxifene and estradiol compared with raloxifene alone on the severity of vasomotor symptoms as well as on the frequency and severity of hot flashes and night sweats
Determine the effects of treatment with combined raloxifene and estradiol in postmenopausal women on endometrial and general safety

Trial Locations

Locations (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