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

Tracking Information

First Received Date ^ICMJE

May 30, 2006

Last Updated Date

May 11, 2007

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00332553 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Vasomotor Symptoms
Endometrial Safety

Intervention ^ICMJE

Drug: Raloxifene
Drug: medroxyprogesterone acetate
Drug: estrogen
Drug: 17 beta estradiol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

May 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

50 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00332553

Responsible Party

Study ID Numbers ^ICMJE

5546, H3S-US-GGKM

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

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

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP