A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT00276094
First received: January 10, 2006
Last updated: May 21, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.


Condition Intervention Phase
Atrophy
Vaginal Diseases
Drug: Ospemifene 30 mg
Drug: Ospemifene 60 mg
Drug: Placebo
Drug: Nonhormonal vaginal lubricant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness [ Time Frame: Baseline (Randomization) to Week 12 ] [ Designated as safety issue: No ]
    This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

  • Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity [ Time Frame: Baseline (Randomization) to Week 12 ] [ Designated as safety issue: No ]
    This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

  • Mean Change From Baseline in Vaginal pH [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Visual Evaluation of the Vagina [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
    Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

  • Change From Baseline in Severity of VVA Symptoms [ Time Frame: Baseline (Randomization) to Week 12 ] [ Designated as safety issue: No ]
    This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

  • Change From Baseline in Estradiol Levels [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Follicle Stimulating Hormone Levels [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Luteinizing Hormone Levels [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Sex Hormone Binding Globulin Levels [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Testosterone (Free) Levels [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Testosterone (Total) Levels [ Time Frame: Baseline (Screening) to Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Urinary Symptoms [ Time Frame: Baseline (Randomization) to Week 12 ] [ Designated as safety issue: No ]

Enrollment: 826
Study Start Date: January 2006
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: Ospemifene 30 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Drug: Ospemifene 30 mg
1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Drug: Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Other Name: K-Y® Brand Jelly
Experimental: Ospemifene 60 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Drug: Ospemifene 60 mg
1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Drug: Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Other Name: K-Y® Brand Jelly
Placebo Comparator: Placebo tablets and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Drug: Placebo
1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Drug: Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Other Name: K-Y® Brand Jelly

  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 postmenopausal
  • Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
  • Vaginal pH greater than 5.0
  • 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

  • Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
  • Abnormal Pap smear
  • Uterine bleeding of unknown origin or uterine polyps
  • Current vaginal infection requiring medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276094

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

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00276094     History of Changes
Other Study ID Numbers: 15-50310
Study First Received: January 10, 2006
Results First Received: March 20, 2013
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

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

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 April 16, 2014