Clinical trial NCT00276094: A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Official title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrophy
Vaginal Diseases
Keywords: Urogenital atrophy
Vaginal atrophy
Vulvar and vaginal atrophy in postmenopausal women
Menopausal symptoms
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hormos Medical
name: QuatRx Pharmaceuticals
First posted: 2006-01-12
Enrollment: 826
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Naturally or surgically postmenopausal
* Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

* Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
* Abnormal Pap smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication

Primary outcomes:
measure: Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness
timeFrame: Baseline (Randomization) to Week 12
measure: Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity
timeFrame: Baseline (Randomization) to Week 12
measure: Mean Change From Baseline in Vaginal pH
timeFrame: Baseline (Screening) to Week 12
measure: Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
timeFrame: Baseline (Screening) to Week 12
measure: Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear
timeFrame: Baseline (Screening) to Week 12
Secondary outcomes:
measure: Change From Baseline in Visual Evaluation of the Vagina
timeFrame: Baseline (Screening) to Week 12
measure: Change From Baseline in Severity of VVA Symptoms
timeFrame: Baseline (Randomization) to Week 12
measure: Change From Baseline in Estradiol Levels
timeFrame: Baseline (Screening) to Week 12
measure: Change From Baseline in Follicle Stimulating Hormone Levels
timeFrame: Baseline (Screening) to Week 12
measure: Change From Baseline in Luteinizing Hormone Levels
timeFrame: Baseline (Screening) to Week 12
measure: Change From Baseline in Sex Hormone Binding Globulin Levels
timeFrame: Baseline (Screening) to Week 12
measure: Change From Baseline in Testosterone (Free) Levels
timeFrame: Baseline (Screening) to Week 12
measure: Change From Baseline in Testosterone (Total) Levels
timeFrame: Baseline (Screening) to Week 12
measure: Change From Baseline in Urinary Symptoms
timeFrame: Baseline (Randomization) to Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: