NCT00276094

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
826

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

June 28, 2013

Completed
Last Updated

June 28, 2013

Status Verified

March 1, 2013

First QC Date

January 10, 2006

Results QC Date

March 20, 2013

Last Update Submit

May 21, 2013

Conditions

AtrophyVaginal Diseases

Keywords

Urogenital atrophyVaginal atrophyVulvar and vaginal atrophy in postmenopausal womenMenopausal symptoms

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Mean Change From Baseline in Vaginal pH

    Baseline (Screening) to Week 12

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

    Baseline (Screening) to Week 12

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

    Baseline (Screening) to Week 12

Secondary Outcomes (9)

  • Change From Baseline in Visual Evaluation of the Vagina

    Baseline (Screening) to Week 12

  • Change From Baseline in Severity of VVA Symptoms

    Baseline (Randomization) to Week 12

  • Change From Baseline in Estradiol Levels

    Baseline (Screening) to Week 12

  • Change From Baseline in Follicle Stimulating Hormone Levels

    Baseline (Screening) to Week 12

  • Change From Baseline in Luteinizing Hormone Levels

    Baseline (Screening) to Week 12

  • +4 more secondary outcomes

Study Arms (3)

Ospemifene 30 mg/day and nonhormonal vaginal lubricant

EXPERIMENTAL

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.

Drug: Ospemifene 30 mgDrug: Nonhormonal vaginal lubricant

Ospemifene 60 mg/day and nonhormonal vaginal lubricant

EXPERIMENTAL

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.

Drug: Ospemifene 60 mgDrug: Nonhormonal vaginal lubricant

Placebo tablets and nonhormonal vaginal lubricant

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Nonhormonal vaginal lubricant

Interventions

Ospemifene 30 mgDRUG

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 30 mg/day and nonhormonal vaginal lubricant
Ospemifene 60 mgDRUG

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).

Ospemifene 60 mg/day and nonhormonal vaginal lubricant
PlaceboDRUG

1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).

Placebo tablets and nonhormonal vaginal lubricant
Nonhormonal vaginal lubricantDRUG

Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

Also known as: K-Y® Brand Jelly
Ospemifene 30 mg/day and nonhormonal vaginal lubricantOspemifene 60 mg/day and nonhormonal vaginal lubricantPlacebo tablets and nonhormonal vaginal lubricant

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • % or fewer superficial cells in maturation index of vaginal smear

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AtrophyVaginal Diseases

Interventions

Ospemifene

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Shionogi Clinical Trials Administrator
Organization
Shionogi Inc.
shionogiclintrialsadmin@shionogi.com
800-849-9707

Study Officials

  • Shionogi Clinical Trials Administrator Clinical Support Help Line

    Shionogi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

January 1, 2006

Study Completion

December 1, 2007

Last Updated

June 28, 2013

Results First Posted

June 28, 2013

Record last verified: 2013-03