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

NCT ID: NCT00332553

Last Updated: 2007-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2004-05-31

Brief Summary

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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

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Conditions

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Vasomotor Symptoms Endometrial Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Raloxifene

Intervention Type DRUG

medroxyprogesterone acetate

Intervention Type DRUG

estrogen

Intervention Type DRUG

17 beta estradiol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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United States

Other Identifiers

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H3S-US-GGKM

Identifier Type: -

Identifier Source: secondary_id

5546

Identifier Type: -

Identifier Source: org_study_id