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

Eli Lilly and Company1 site in 1 country150 target enrollmentFebruary 2002

ConditionsVasomotor Symptoms Endometrial Safety

DrugsRaloxifene medroxyprogesterone acetate estrogen 17 beta estradiol

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Vasomotor Symptoms
Sponsor: Eli Lilly and Company
Enrollment: 150
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

May 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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