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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Medroxyprogesterone; Medroxyprogesterone Acetate; Polyestradiol phosphate; Raloxifene Hydrochloride

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