Vaginal Atrophy
Conditions
Keywords
Vaginal Atrophy, Postmenopause
Brief summary
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Generally healthy, postmenopausal women, aged 40 to 65 years * Intact uterus * At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome
Exclusion criteria
* Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia * Thrombophlebitis, thrombosis or thromboembolic disorders * Neuro-ocular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12. | — |
| Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal pH at screening, and weeks 4 and 12. | — |
| Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12. | — |
Countries
United States
Outcome results
None listed