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Completed

NCT Number: NCT00729469

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

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.

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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 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

Treatment and study plan

Ospemifene 60 mg

Drug

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 names: Osphena®

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

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 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2008
Registry last updated
May 18, 2018

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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