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A Clinical Study to Evaluate the Safety of Ospemifene

This study has been completed.
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT00566982
First received: November 30, 2007
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Ospemifene
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Mean change in percentage of superficial cells in maturation index of vaginal smear [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in vaginal pH [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in serum hormone levels [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in visual evaluation of the vagina [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566982

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

No publications provided

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00566982     History of Changes
Other Study ID Numbers: 15-50718
Study First Received: November 30, 2007
Last Updated: April 18, 2012
Health Authority: Sweden: Institutional Review Board
United States: Food and Drug Administration
Belgium: Directorate general for the protection of Public health: Medicines
Denmark: Danish Dataprotection Agency
Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 23, 2013