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CompletedNCT00332553Updated May 15, 2007

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

A Phase 2 interventional study of Raloxifene and medroxyprogesterone acetate in Vasomotor Symptoms and Endometrial Safety, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-05-15.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Vasomotor Symptoms
  • Endometrial Safety
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
150 participants

Interventions

  • DrugRaloxifene
  • Drugmedroxyprogesterone acetate
  • Drugestrogen
  • Drug17 beta estradiol
06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Determine the effects of treatment with combined raloxifene and estradiol in postmenopausal women on endometrial and general safety

07

Study locations

1 site
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00332553
Lead sponsor
Eli Lilly and Company
First posted
Jun 1, 2006
Start date
Feb 2002
Completion
May 2004
Last update
May 15, 2007

Study contacts

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 · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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