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A Clinical Study to Evaluate the Safety of Ospemifene

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566982
First Posted: December 4, 2007
Last Update Posted: June 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
  Purpose
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.

Condition Intervention Phase
Atrophy Vaginal Diseases Drug: Ospemifene 60 mg Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear [ Time Frame: 12 weeks ]
  • Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear [ Time Frame: 12 weeks ]
  • Mean Change From Baseline in Vaginal pH [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change From Baseline in Estradiol Levels [ Time Frame: 52 weeks ]
  • Change From Baseline in Luteinizing Hormone Levels [ Time Frame: 52 weeks ]
  • Change From Baseline in Follicle Stimulating Hormone Levels [ Time Frame: 52 weeks ]
  • Change From Baseline in Sex Hormone Binding Globulin Levels [ Time Frame: 52 weeks ]
  • Visual Evaluation of the Vagina (Baseline & Week 52) [ Time Frame: 52 weeks ]

Enrollment: 426
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects on ospemifene 60 mg/day
Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.
Drug: Ospemifene 60 mg
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.
Placebo Comparator: Subjects on placebo
Placebo will be taken once daily, in the morning, with food for 52 weeks.
Drug: Placebo
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566982


Sponsors and Collaborators
Shionogi
Hormos Medical
QuatRx Pharmaceuticals
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00566982     History of Changes
Other Study ID Numbers: 15-50718
First Submitted: November 30, 2007
First Posted: December 4, 2007
Results First Submitted: March 19, 2013
Results First Posted: June 28, 2013
Last Update Posted: June 28, 2013
Last Verified: March 2013

Keywords provided by Shionogi Inc.:
Urogenital atrophy
Menopausal symptoms
Vulvar and vaginal atrophy in postmenopausal women
Vaginal atrophy

Additional relevant MeSH terms:
Vaginal Diseases
Pathological Conditions, Anatomical
Genital Diseases, Female
Atrophy
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents