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

Lilly

Status and phase

Completed

Phase 2

Conditions

Vasomotor Symptoms

Endometrial Safety

Treatments

Drug: medroxyprogesterone acetate

Drug: 17 beta estradiol

Drug: Raloxifene

Drug: estrogen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00332553

H3S-US-GGKM

5546

Details and patient eligibility

About

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.

Sex

Female

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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