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Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Primary Purpose

Atrophy, Vaginal Diseases

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ospemifene 60 mg

Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Naturally or surgically menopausal
Moderate or severe symptoms of vaginal atrophy
5% or fewer superficial cells in maturation index of vaginal smear
Vaginal pH greater than 5.0
Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Exclusion Criteria:

Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
Current vaginal infection requiring medication
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.

uterine or vaginal prolapse of Grade 2 or higher)

Previous participation in any other ospemifene study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ospemifene 60 mg/day and K-Y® lubricant

Placebo and K-Y® lubricant

Arm Description

Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)

Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)

Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)

Secondary Outcome Measures

Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)

Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)

Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)

Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)

Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)

Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)

Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)

Full Information

NCT ID

NCT00729469

First Posted

August 4, 2008

Last Updated

April 19, 2018

Sponsor

Shionogi

Collaborators

Hormos Medical, QuatRx Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00729469

Brief Title

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Official Title

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

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 the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrophy, Vaginal Diseases

Keywords

Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms, Vaginal atrophy, Urogenital atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

919 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ospemifene 60 mg/day and K-Y® lubricant

Arm Type

Experimental

Arm Description

Arm Title

Placebo and K-Y® lubricant

Arm Type

Placebo Comparator

Arm Description

Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Intervention Type

Drug

Intervention Name(s)

Ospemifene 60 mg

Other Intervention Name(s)

Osphena®

Intervention Description

60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Primary Outcome Measure Information:

Title

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)

Time Frame

12 weeks

Title

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)

Time Frame

12 weeks

Title

Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)

Time Frame

12 weeks

Title

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

Time Frame

12 weeks

Title

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)

Time Frame

12 weeks

Title

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)

Time Frame

12 weeks

Title

Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)

Time Frame

12 weeks

Title

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)

Time Frame

4 weeks

Title

Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)

Time Frame

4 weeks

Title

Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)

Time Frame

4 weeks

Title

Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

Time Frame

4 weeks

Title

Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)

Time Frame

4 weeks

Title

Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)

Time Frame

4 weeks

Title

Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)

Time Frame

4 weeks

Title

Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)

Time Frame

4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Naturally or surgically menopausal Moderate or severe symptoms of vaginal atrophy 5% or fewer superficial cells in maturation index of vaginal smear Vaginal pH greater than 5.0 Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization Exclusion Criteria: Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids Current vaginal infection requiring medication Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g. uterine or vaginal prolapse of Grade 2 or higher) Previous participation in any other ospemifene study

12. IPD Sharing Statement

Citations:

PubMed Identifier

23361170

Citation

Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.

Results Reference

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Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

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