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Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

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ClinicalTrials.gov Identifier: NCT00729469
Recruitment Status : Completed
First Posted : August 7, 2008
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 )

Study Description
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Brief Summary:
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 919 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women
Study Start Date : July 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ospemifene

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ospemifene 60 mg/day and K-Y® lubricant
Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.
 Drug: Ospemifene 60 mg
60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
Other Name: Osphena®
Placebo Comparator: Placebo and K-Y® lubricant
Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.
 Drug: Placebo
oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) [ Time Frame: 12 weeks ]
  2. Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) [ Time Frame: 12 weeks ]
  3. Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) [ Time Frame: 12 weeks ]
  4. Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) [ Time Frame: 12 weeks ]
  5. Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) [ Time Frame: 12 weeks ]
  6. Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) [ Time Frame: 12 weeks ]
  7. Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) [ Time Frame: 12 weeks ]
  8. Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) [ Time Frame: 4 weeks ]
  2. Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) [ Time Frame: 4 weeks ]
  3. Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) [ Time Frame: 4 weeks ]
  4. Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) [ Time Frame: 4 weeks ]
  5. Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) [ Time Frame: 4 weeks ]
  6. Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) [ Time Frame: 4 weeks ]
  7. Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) [ Time Frame: 4 weeks ]
  8. Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) [ Time Frame: 4 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
  • Moderate or severe symptoms of vaginal atrophy
  • 5% or fewer superficial cells in maturation index of vaginal smear
  • Vaginal pH greater than 5.0
  • Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Exclusion Criteria:

  • Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
  • Current vaginal infection requiring medication
  • Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.

uterine or vaginal prolapse of Grade 2 or higher)

  • Previous participation in any other ospemifene study
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT00729469    
Other Study ID Numbers: 15-50821
First Posted: August 7, 2008    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 ):
Vulvar and vaginal atrophy in postmenopausal women
Menopausal symptoms
Vaginal atrophy
Urogenital atrophy
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaginal Diseases
Atrophy
Pathological Conditions, Anatomical