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OpenTrials
Completed

NCT Number: NCT00332553

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

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.

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Key information

Conditions

Vasomotor Symptoms Endometrial Safety

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raloxifene

Drug

Medroxyprogesterone Acetate

Drug

Estrogen

Drug

17 beta estradiol

Drug

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Jun 1, 2006
Registry last updated
May 15, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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