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

Primary Purpose

Atrophy, Vaginal Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ospemifene 30 mg
Ospemifene 60 mg
Placebo
Nonhormonal vaginal lubricant
Sponsored by
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy focused on measuring Urogenital atrophy, Vaginal atrophy, Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Ospemifene 30 mg/day and nonhormonal vaginal lubricant

    Ospemifene 60 mg/day and nonhormonal vaginal lubricant

    Placebo tablets and nonhormonal vaginal lubricant

    Arm Description

    Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

    Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

    Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

    Outcomes

    Primary Outcome Measures

    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
    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
    Mean Change From Baseline in Vaginal pH
    Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
    Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear

    Secondary Outcome Measures

    Change From Baseline in Visual Evaluation of the Vagina
    Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
    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
    Change From Baseline in Estradiol Levels
    Change From Baseline in Follicle Stimulating Hormone Levels
    Change From Baseline in Luteinizing Hormone Levels
    Change From Baseline in Sex Hormone Binding Globulin Levels
    Change From Baseline in Testosterone (Free) Levels
    Change From Baseline in Testosterone (Total) Levels
    Change From Baseline in Urinary Symptoms

    Full Information

    First Posted
    January 10, 2006
    Last Updated
    May 21, 2013
    Sponsor
    Shionogi
    Collaborators
    Hormos Medical, QuatRx Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00276094
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shionogi
    Collaborators
    Hormos Medical, QuatRx Pharmaceuticals

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrophy, Vaginal Diseases
    Keywords
    Urogenital atrophy, Vaginal atrophy, Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    826 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ospemifene 30 mg/day and nonhormonal vaginal lubricant
    Arm Type
    Experimental
    Arm Description
    Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
    Arm Title
    Ospemifene 60 mg/day and nonhormonal vaginal lubricant
    Arm Type
    Experimental
    Arm Description
    Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
    Arm Title
    Placebo tablets and nonhormonal vaginal lubricant
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
    Intervention Type
    Drug
    Intervention Name(s)
    Ospemifene 30 mg
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Ospemifene 60 mg
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
    Intervention Type
    Drug
    Intervention Name(s)
    Nonhormonal vaginal lubricant
    Other Intervention Name(s)
    K-Y® Brand Jelly
    Intervention Description
    Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness
    Description
    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
    Time Frame
    Baseline (Randomization) to Week 12
    Title
    Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity
    Description
    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
    Time Frame
    Baseline (Randomization) to Week 12
    Title
    Mean Change From Baseline in Vaginal pH
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear
    Time Frame
    Baseline (Screening) to Week 12
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Visual Evaluation of the Vagina
    Description
    Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Change From Baseline in Severity of VVA Symptoms
    Description
    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
    Time Frame
    Baseline (Randomization) to Week 12
    Title
    Change From Baseline in Estradiol Levels
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Change From Baseline in Follicle Stimulating Hormone Levels
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Change From Baseline in Luteinizing Hormone Levels
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Change From Baseline in Sex Hormone Binding Globulin Levels
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Change From Baseline in Testosterone (Free) Levels
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Change From Baseline in Testosterone (Total) Levels
    Time Frame
    Baseline (Screening) to Week 12
    Title
    Change From Baseline in Urinary Symptoms
    Time Frame
    Baseline (Randomization) to Week 12

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shionogi Clinical Trials Administrator Clinical Support Help Line
    Organizational Affiliation
    Shionogi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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