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

Eli Lilly and Company150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Vasomotor Symptoms Endometrial Safety

Interventions

RaloxifeneDRUG

medroxyprogesterone acetateDRUG

estrogenDRUG

17 beta estradiolDRUG

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

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

Data from ClinicalTrials.gov

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