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

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00332553

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 II

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:

MedlinePlus related topics: Sweat

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Raloxifene hydrochloride Raloxifene Medroxyprogesterone 17-acetate Estradiol dipropionate Estradiol cypionate Medroxyprogesterone Estradiol valerate Estradiol acetate

U.S. FDA Resources

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 Acetate
Medroxyprogesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents

Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on February 12, 2012