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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00332553
First received: May 30, 2006
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Vasomotor Symptoms
Endometrial Safety
Drug: Raloxifene
Drug: medroxyprogesterone acetate
Drug: estrogen
Drug: 17 beta estradiol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: February 2002
Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332553

Locations
United States, Indiana
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00332553     History of Changes
Other Study ID Numbers: 5546, H3S-US-GGKM
Study First Received: May 30, 2006
Last Updated: May 11, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estrogens
Raloxifene
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on April 17, 2014