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A Clinical Study to Evaluate the Safety of Ospemifene

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ClinicalTrials.gov Identifier: NCT00566982
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : June 28, 2013
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

November 30, 2007
December 4, 2007
March 19, 2013
June 28, 2013
May 18, 2018
October 2007
July 2009   (Final data collection date for primary outcome measure)
  • 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 ]
  • Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear [ Time Frame: 52 weeks ]
  • Mean change in percentage of superficial cells in maturation index of vaginal smear [ Time Frame: 52 weeks ]
  • Mean Change From Baseline in Vaginal pH [ Time Frame: 52 weeks ]
Complete list of historical versions of study NCT00566982 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in serum hormone levels [ Time Frame: 52 weeks ]
  • Change from baseline in visual evaluation of the vagina [ Time Frame: 52 weeks ]
Not Provided
Not Provided
 
A Clinical Study to Evaluate the Safety of Ospemifene
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Atrophy
  • Vaginal Diseases
  • 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.
    Other Name: Osphena®
  • 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)
  • Experimental: Ospemifene 60 mg/day
    Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.
    Intervention: Drug: Ospemifene 60 mg
  • Placebo Comparator: Placebo
    Placebo will be taken once daily, in the morning, with food for 52 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
426
350
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
40 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium,   Denmark,   Finland,   Sweden
 
NCT00566982
15-50718
Not Provided
Not Provided
Not Provided
Shionogi Inc. ( Shionogi )
Shionogi
  • Hormos Medical
  • QuatRx Pharmaceuticals
Not Provided
Shionogi Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP