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A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

Primary Purpose

Atrophy, Vaginal Diseases

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Placebo

Ospemifene 5 mg

Ospemifene 15 mg

Ospemifene 30 mg

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Naturally or surgically menopausal
Vaginal pH greater than 5.0
5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

Evidence of endometrial hyperplasia, cancer or other pathology
Abnormal PAP smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication
Use of hormonal medications
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Subjects on placebo

Subjects on ospemifene 5 mg/day

Subjects on ospemifene 15 mg/day

Subjects on ospemifene 30 mg/day

Arm Description

Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks

Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks

Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks

Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Outcomes

Primary Outcome Measures

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

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

Mean Change From Baseline in Vaginal pH

Secondary Outcome Measures

Visual Evaluation of Vagina (by Gynecological Examination)

Mean Change From Baseline in Vaginal pH

Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index

Mean Change From Baseline in Estradiol Levels

Mean Change From Baseline in Luteinizing Hormone Levels

Mean Change From Baseline in Follicle Stimulating Hormone Levels

Mean Change From Baseline in Sex Hormone Binding Globulin Levels

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index

Full Information

NCT ID

NCT00630539

First Posted

February 28, 2008

Last Updated

May 21, 2013

Sponsor

Shionogi

Collaborators

Hormos Medical, QuatRx Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00630539

Brief Title

A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

Official Title

Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shionogi

Collaborators

Hormos Medical, QuatRx Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

6. Conditions and Keywords

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

Atrophy, Vaginal Diseases

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects on placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks

Arm Title

Subjects on ospemifene 5 mg/day

Arm Type

Experimental

Arm Description

Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks

Arm Title

Subjects on ospemifene 15 mg/day

Arm Type

Experimental

Arm Description

Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks

Arm Title

Subjects on ospemifene 30 mg/day

Arm Type

Experimental

Arm Description

Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Intervention Type

Drug

Intervention Name(s)

Ospemifene 5 mg

Intervention Description

1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Intervention Type

Drug

Intervention Name(s)

Ospemifene 15 mg

Intervention Description

1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Intervention Type

Drug

Intervention Name(s)

Ospemifene 30 mg

Intervention Description

1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

Mean Change From Baseline in Vaginal pH

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Visual Evaluation of Vagina (by Gynecological Examination)

Time Frame

Screening & Week 12

Title

Mean Change From Baseline in Vaginal pH

Time Frame

Week 4

Title

Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index

Time Frame

Week 4

Title

Mean Change From Baseline in Estradiol Levels

Time Frame

Week 12

Title

Mean Change From Baseline in Luteinizing Hormone Levels

Time Frame

Week 12

Title

Mean Change From Baseline in Follicle Stimulating Hormone Levels

Time Frame

Week 12

Title

Mean Change From Baseline in Sex Hormone Binding Globulin Levels

Time Frame

Week 12

Title

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index

Time Frame

Week 4

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 Vaginal pH greater than 5.0 5% or fewer superficial cells in maturation index of vaginal smear Exclusion Criteria: Evidence of endometrial hyperplasia, cancer or other pathology Abnormal PAP smear Uterine bleeding of unknown origin or uterine polyps Current vaginal infection requiring medication Use of hormonal medications Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

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 the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

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