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Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Vaginal Atrophy

Treatments

Drug: Bazedoxifene/Conjugated Estrogen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00238732
3115A1-306

Details and patient eligibility

About

The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

63

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Data sourced from clinicaltrials.gov

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