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

Vasomotor Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332553
• Other study ID #: 5546
• Secondary ID: H3S-US-GGKM
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: May 11, 2007
• Start date: February 2002
• Est. completion date: May 2004

Study information

• Verified date: May 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometrial Safety
• Vasomotor Symptoms

Intervention

Drug:
• Raloxifene

• medroxyprogesterone acetate

• estrogen

• 17 beta estradiol

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Determine the effects of treatment with combined raloxifene and estradiol in postmenopausal women on endometrial and general safety