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A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00630539
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.

Brief Summary:
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

Condition or disease Intervention/treatment Phase
Atrophy Vaginal Diseases Drug: Placebo Drug: Ospemifene 5 mg Drug: Ospemifene 15 mg Drug: Ospemifene 30 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo
Study Start Date : August 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Placebo Comparator: Subjects on placebo
Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks
Drug: Placebo
1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Experimental: Subjects on ospemifene 5 mg/day
Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Drug: Ospemifene 5 mg
1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Experimental: Subjects on ospemifene 15 mg/day
Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Drug: Ospemifene 15 mg
1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Experimental: Subjects on ospemifene 30 mg/day
Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Drug: Ospemifene 30 mg
1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).



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

Secondary Outcome Measures :
  1. Visual Evaluation of Vagina (by Gynecological Examination) [ Time Frame: Screening & Week 12 ]
  2. Mean Change From Baseline in Vaginal pH [ Time Frame: Week 4 ]
  3. Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index [ Time Frame: Week 4 ]
  4. Mean Change From Baseline in Estradiol Levels [ Time Frame: Week 12 ]
  5. Mean Change From Baseline in Luteinizing Hormone Levels [ Time Frame: Week 12 ]
  6. Mean Change From Baseline in Follicle Stimulating Hormone Levels [ Time Frame: Week 12 ]
  7. Mean Change From Baseline in Sex Hormone Binding Globulin Levels [ Time Frame: Week 12 ]
  8. Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index [ Time Frame: Week 4 ]


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
  • 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

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): NCT00630539


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

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00630539     History of Changes
Other Study ID Numbers: 15-50717
First Posted: March 7, 2008    Key Record Dates
Results First Posted: June 28, 2013
Last Update Posted: June 28, 2013
Last Verified: March 2013

Keywords provided by Shionogi Inc.:
Menopausal symptoms
Urogenital atrophy
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