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

NCT00332553 | Completed Phase 2

• 2 other identifiers: 5546H3S-US-GGKM
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasomotor Symptoms; Endometrial Safety

Outcome Measures

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 (2)

• 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

Interventions

Raloxifene DRUG

medroxyprogesterone acetate DRUG

estrogen DRUG

17 beta estradiol DRUG

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Interventions

Raloxifene Hydrochloride; Medroxyprogesterone Acetate; Estrogens; Estradiol

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: June 1, 2006
• Study Start: February 1, 2002
• Study Completion: May 1, 2004
• Last Updated: May 15, 2007

Record last verified: 2007-05

Locations

US (1)