Endometrial Safety, Vasomotor Symptoms
Conditions
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed