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A Clinical Study to Evaluate the Safety of Ospemifene

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 Urogenital atrophy, Menopausal symptoms, 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
Intact uterus
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 Type

Experimental

Placebo Comparator

Arm Label

Ospemifene 60 mg/day

Placebo

Arm Description

Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.

Placebo will be taken once daily, in the morning, with food for 52 weeks.

Outcomes

Primary Outcome Measures

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

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

Mean Change From Baseline in Vaginal pH

Secondary Outcome Measures

Change From Baseline in Estradiol Levels

Change From Baseline in Luteinizing Hormone Levels

Change From Baseline in Follicle Stimulating Hormone Levels

Change From Baseline in Sex Hormone Binding Globulin Levels

Visual Evaluation of the Vagina (Baseline & Week 52)

Full Information

NCT ID

NCT00566982

First Posted

November 30, 2007

Last Updated

April 19, 2018

Sponsor

Shionogi

Collaborators

Hormos Medical, QuatRx Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00566982

Brief Title

A Clinical Study to Evaluate the Safety of Ospemifene

Official Title

Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 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 efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

426 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ospemifene 60 mg/day

Arm Type

Experimental

Arm Description

Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo will be taken once daily, in the morning, with food for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Ospemifene 60 mg

Other Intervention Name(s)

Osphena®

Intervention Description

60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

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

Time Frame

12 weeks

Title

Mean Change From Baseline in Vaginal pH

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Estradiol Levels

Time Frame

52 weeks

Title

Change From Baseline in Luteinizing Hormone Levels

Time Frame

52 weeks

Title

Change From Baseline in Follicle Stimulating Hormone Levels

Time Frame

52 weeks

Title

Change From Baseline in Sex Hormone Binding Globulin Levels

Time Frame

52 weeks

Title

Visual Evaluation of the Vagina (Baseline & Week 52)

Time Frame

52 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 Intact uterus 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

12. IPD Sharing Statement

Learn more about this trial

A Clinical Study to Evaluate the Safety of Ospemifene

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