Phase 3 N=826 Randomized Double-blind Treatment

A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

Atrophy · Vaginal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00276094 ↗

Enrolled (actual)

826

Serious AEs

1.1%

Results posted

Jun 2013

Primary outcome: Primary: Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness — -1.22; -1.26; -0.84 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ospemifene 30 mg (Drug); Ospemifene 60 mg (Drug); Placebo (Drug); Nonhormonal vaginal lubricant (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Shionogi
Primary completion: —

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness	-1.22; -1.26; -0.84	—
PRIMARY Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity	-1.02; -1.19; -0.89	—
PRIMARY Mean Change From Baseline in Vaginal pH	-0.67; -1.01; -0.096	—
PRIMARY Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear	-21.9; -30.1; 3.98	—
PRIMARY Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear	7.78; 10.8; 2.18	—
SECONDARY Change From Baseline in Visual Evaluation of the Vagina	-0.50; -0.60; -0.037; -0.75; -0.93; -0.30	—
SECONDARY Change From Baseline in Severity of VVA Symptoms	-0.96; -1.17; -0.63; -0.77; -0.87; -0.57	—
SECONDARY Change From Baseline in Estradiol Levels	-1.44; 1.02; 0.30	—
SECONDARY Change From Baseline in Follicle Stimulating Hormone Levels	-5.93; -8.71; -1.33	—
SECONDARY Change From Baseline in Luteinizing Hormone Levels	-2.85; -3.73; 0.41	—
SECONDARY Change From Baseline in Sex Hormone Binding Globulin Levels	11.1; 22.8; -2.17	—
SECONDARY Change From Baseline in Testosterone (Free) Levels	0.002; -0.031; -0.008	—
SECONDARY Change From Baseline in Testosterone (Total) Levels	1.55; 1.92; -0.059	—
SECONDARY Change From Baseline in Urinary Symptoms	49; 63; 60; 24; 25; 22	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00276094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.