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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729469
First Posted: August 7, 2008
Last Update Posted: June 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
August 4, 2008
August 7, 2008
March 19, 2013
June 28, 2013
June 28, 2013
July 2008
August 2009   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) [ Time Frame: 12 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) [ Time Frame: 12 weeks ]
  • 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 ]
  • Change from baseline to week 12 in percentage of parabasal cells in the maturation index of the vaginal smear [ Time Frame: 12 weeks ]
  • Change from baseline to week 12 in percentage of superficial cells in the maturation index of the vaginal smear [ Time Frame: 12 weeks ]
  • Change from baseline to week 12 in vaginal pH. [ Time Frame: 12 weeks ]
  • Change from baseline to week 12 in severity of the most bothersome symptom of vaginal dryness and vaginal pain associated with sexual activity. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00729469 on ClinicalTrials.gov Archive Site
  • Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) [ Time Frame: 4 weeks ]
  • Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) [ Time Frame: 4 weeks ]
  • Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) [ Time Frame: 4 weeks ]
  • 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 ]
  • Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) [ Time Frame: 4 weeks ]
  • 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 ]
  • Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) [ Time Frame: 4 weeks ]
  • Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) [ Time Frame: 4 weeks ]
  • Change from baseline in percentage of parabasal cells in the maturation index [ Time Frame: 4 weeks ]
  • Change from baseline in percentage of superficial cells in the maturation index [ Time Frame: 4 weeks ]
  • Change from baseline in vaginal pH [ Time Frame: Week 4 ]
  • Change from baseline in severity of most bothersome symptom of vaginal dryness and vaginal pain associated with sexual activity [ Time Frame: Week 4 ]
Not Provided
Not Provided
 
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Atrophy
  • Vaginal Diseases
  • 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)
  • Drug: Placebo
  • Drug: Non-hormonal vaginal lubricant
    Vaginal lubricant should be used as needed
  • Experimental: Subjects on ospemifene 60 mg/day and non-hormonal 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.
    Interventions:
    • Drug: Ospemifene 60 mg
    • Drug: Non-hormonal vaginal lubricant
  • Placebo Comparator: Subjects on placebo and non-hormonal vaginal lubricant
    Interventions:
    • Drug: Placebo
    • Drug: Non-hormonal vaginal lubricant
Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
919
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00729469
15-50821
Not Provided
Not Provided
Not Provided
Shionogi Clinical Trials Administrator, Shionogi
Shionogi
  • Hormos Medical
  • QuatRx Pharmaceuticals
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
Shionogi Inc.
March 2013

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