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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 )

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.

Condition or disease Intervention/treatment Phase
Atrophy Vaginal Diseases Drug: Ospemifene 60 mg Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ospemifene

Arm Intervention/treatment
Experimental: 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.
Other Name: Osphena®

Placebo Comparator: 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)




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

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


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
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

Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT00566982     History of Changes
Other Study ID Numbers: 15-50718
First Posted: December 4, 2007    Key Record Dates
Results First Posted: June 28, 2013
Last Update Posted: May 18, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Atrophy
Vaginal Diseases
Pathological Conditions, Anatomical
Genital Diseases, Female
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