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Completed

NCT Number: NCT00566982

A Clinical Study to Evaluate the Safety of Ospemifene

The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

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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
  • Intact uterus
  • Vaginal pH greater than 5.0
  • 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion criteria

  • Evidence of endometrial hyperplasia, cancer or other pathology
  • Abnormal Pap smear
  • Uterine bleeding of unknown origin or uterine polyps
  • Current vaginal infection requiring medication
  • Use of hormonal medications
  • Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Treatment and study plan

Ospemifene 60 mg

Drug

60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.

Other names: Osphena®

Placebo

Drug

Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  3. Mean Change From Baseline in Vaginal pH

    Time frame: 12 weeks

Secondary outcomes

  1. Change From Baseline in Estradiol Levels

    Time frame: 52 weeks

  2. Change From Baseline in Luteinizing Hormone Levels

    Time frame: 52 weeks

  3. Change From Baseline in Follicle Stimulating Hormone Levels

    Time frame: 52 weeks

  4. Change From Baseline in Sex Hormone Binding Globulin Levels

    Time frame: 52 weeks

  5. Visual Evaluation of the Vagina (Baseline & Week 52)

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Collaborators

  • Hormos Medical
  • QuatRx Pharmaceuticals

Registry information

Official study title

Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 4, 2007
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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