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Completed

NCT Number: NCT00276094

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

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.

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Key information

Conditions

Atrophy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Vaginal Diseases

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ospemifene 30 mg

Drug

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).

Ospemifene 60 mg

Drug

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).

Placebo

Drug

1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).

Nonhormonal vaginal lubricant

Drug

Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

Other names: K-Y® Brand Jelly

Primary outcomes

  1. 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

    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

  2. Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity

    Time frame: Baseline (Randomization) to Week 12

    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

  3. Mean Change From Baseline in Vaginal pH

    Time frame: Baseline (Screening) to Week 12

  4. Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear

    Time frame: Baseline (Screening) to Week 12

  5. Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear

    Time frame: Baseline (Screening) to Week 12

Secondary outcomes

  1. Change From Baseline in Visual Evaluation of the Vagina

    Time frame: Baseline (Screening) to Week 12

    Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

  2. Change From Baseline in Severity of VVA Symptoms

    Time frame: Baseline (Randomization) to Week 12

    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

  3. Change From Baseline in Estradiol Levels

    Time frame: Baseline (Screening) to Week 12

  4. Change From Baseline in Follicle Stimulating Hormone Levels

    Time frame: Baseline (Screening) to Week 12

  5. Change From Baseline in Luteinizing Hormone Levels

    Time frame: Baseline (Screening) to Week 12

  6. Change From Baseline in Sex Hormone Binding Globulin Levels

    Time frame: Baseline (Screening) to Week 12

  7. Change From Baseline in Testosterone (Free) Levels

    Time frame: Baseline (Screening) to Week 12

  8. Change From Baseline in Testosterone (Total) Levels

    Time frame: Baseline (Screening) to Week 12

  9. Change From Baseline in Urinary Symptoms

    Time frame: Baseline (Randomization) to Week 12

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Collaborators

  • Hormos Medical
  • QuatRx Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Jan 12, 2006
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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