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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00276094
Other study ID # 15-50310
Secondary ID
Status Completed
Phase Phase 3
First received January 10, 2006
Last updated May 21, 2013
Start date January 2006
Est. completion date December 2007

Study information

Verified date March 2013
Source Shionogi Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 826
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ospemifene 30 mg
1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Ospemifene 60 mg
1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Placebo
1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Shionogi Hormos Medical, QuatRx Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe Baseline (Randomization) to Week 12 No
Primary Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe Baseline (Randomization) to Week 12 No
Primary Mean Change From Baseline in Vaginal pH Baseline (Screening) to Week 12 No
Primary Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear Baseline (Screening) to Week 12 No
Primary Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Visual Evaluation of the Vagina Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Severity of VVA Symptoms This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe Baseline (Randomization) to Week 12 No
Secondary Change From Baseline in Estradiol Levels Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Follicle Stimulating Hormone Levels Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Luteinizing Hormone Levels Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Sex Hormone Binding Globulin Levels Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Testosterone (Free) Levels Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Testosterone (Total) Levels Baseline (Screening) to Week 12 No
Secondary Change From Baseline in Urinary Symptoms Baseline (Randomization) to Week 12 No
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