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:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT00729469
First received: August 4, 2008
Last updated: May 21, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Atrophy
Vaginal Diseases
Drug: Ospemifene 60 mg
Drug: Placebo
Drug: Non-hormonal vaginal lubricant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 919
Study Start Date: July 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Non-hormonal vaginal lubricant
Vaginal lubricant should be used as needed
Placebo Comparator: Subjects on placebo and non-hormonal vaginal lubricant Drug: Placebo Drug: Non-hormonal vaginal lubricant
Vaginal lubricant should be used as needed

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729469

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

No publications provided by Shionogi Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00729469     History of Changes
Other Study ID Numbers: 15-50821
Study First Received: August 4, 2008
Results First Received: March 19, 2013
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Vaginal Diseases
Atrophy
Genital Diseases, Female
Pathological Conditions, Anatomical
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 29, 2014