NCT00630539

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

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

August 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

June 28, 2013

Completed
Last Updated

June 28, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

February 28, 2008

Results QC Date

March 19, 2013

Last Update Submit

May 21, 2013

Conditions

AtrophyVaginal Diseases

Keywords

Menopausal symptomsUrogenital atrophyVulvar and vaginal atrophy in postmenopausal womenVaginal atrophy

Outcome Measures

Primary Outcomes (3)

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

    12 weeks

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

    12 weeks

  • Mean Change From Baseline in Vaginal pH

    12 weeks

Secondary Outcomes (8)

  • Visual Evaluation of Vagina (by Gynecological Examination)

    Screening & Week 12

  • Mean Change From Baseline in Vaginal pH

    Week 4

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

    Week 4

  • Mean Change From Baseline in Estradiol Levels

    Week 12

  • Mean Change From Baseline in Luteinizing Hormone Levels

    Week 12

  • +3 more secondary outcomes

Study Arms (4)

Subjects on placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Subjects on ospemifene 5 mg/day

EXPERIMENTAL

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

Drug: Ospemifene 5 mg

Subjects on ospemifene 15 mg/day

EXPERIMENTAL

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

Drug: Ospemifene 15 mg

Subjects on ospemifene 30 mg/day

EXPERIMENTAL

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

Drug: Ospemifene 30 mg

Interventions

PlaceboDRUG

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).

Subjects on placebo
Ospemifene 5 mgDRUG

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).

Subjects on ospemifene 5 mg/day
Ospemifene 15 mgDRUG

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).

Subjects on ospemifene 15 mg/day
Ospemifene 30 mgDRUG

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).

Subjects on ospemifene 30 mg/day

Eligibility Criteria

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

You may qualify if:

  • Naturally or surgically menopausal
  • 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, 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

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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

June 28, 2013

Results First Posted

June 28, 2013

Record last verified: 2013-03