NCT00566982

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
4 years until next milestone

Results Posted

Study results publicly available

June 28, 2013

Completed
Last Updated

May 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

November 30, 2007

Results QC Date

March 19, 2013

Last Update Submit

April 19, 2018

Conditions

AtrophyVaginal Diseases

Keywords

Urogenital atrophyMenopausal symptomsVulvar and vaginal atrophy in postmenopausal womenVaginal atrophy

Outcome Measures

Primary Outcomes (3)

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

    12 weeks

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

    12 weeks

  • Mean Change From Baseline in Vaginal pH

    12 weeks

Secondary Outcomes (5)

  • Change From Baseline in Estradiol Levels

    52 weeks

  • Change From Baseline in Luteinizing Hormone Levels

    52 weeks

  • Change From Baseline in Follicle Stimulating Hormone Levels

    52 weeks

  • Change From Baseline in Sex Hormone Binding Globulin Levels

    52 weeks

  • Visual Evaluation of the Vagina (Baseline & Week 52)

    52 weeks

Study Arms (2)

Ospemifene 60 mg/day

EXPERIMENTAL

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

Drug: Ospemifene 60 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ospemifene 60 mgDRUG

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.

Also known as: Osphena®
Ospemifene 60 mg/day
PlaceboDRUG

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)

Placebo

Eligibility Criteria

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

You may qualify if:

  • Naturally or surgically menopausal
  • Intact uterus
  • 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.
Shionogiclintrials-admin@shionogi.co.jp
800-849-9707

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 18, 2018

Results First Posted

June 28, 2013

Record last verified: 2018-04