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

Condition(s) targeted: Vasomotor Symptoms; Endometrial Safety

Intervention: Raloxifene (Drug); medroxyprogesterone acetate (Drug); estrogen (Drug); 17 beta estradiol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

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

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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

Minimum age: 50 Years. Maximum age: 70 Years. Gender(s): Female.

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

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

Starting date: February 2002
Ending date: May 2004
Last updated: May 11, 2007