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Completed

NCT Number: NCT00630539

A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

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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 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Naturally or surgically menopausal
  • 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

Placebo

Drug

1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Ospemifene 5 mg

Drug

1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Ospemifene 15 mg

Drug

1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Ospemifene 30 mg

Drug

1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  3. Mean Change From Baseline in Vaginal pH

    Time frame: 12 weeks

Secondary outcomes

  1. Visual Evaluation of Vagina (by Gynecological Examination)

    Time frame: Screening & Week 12

  2. Mean Change From Baseline in Vaginal pH

    Time frame: Week 4

  3. Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index

    Time frame: Week 4

  4. Mean Change From Baseline in Estradiol Levels

    Time frame: Week 12

  5. Mean Change From Baseline in Luteinizing Hormone Levels

    Time frame: Week 12

  6. Mean Change From Baseline in Follicle Stimulating Hormone Levels

    Time frame: Week 12

  7. Mean Change From Baseline in Sex Hormone Binding Globulin Levels

    Time frame: Week 12

  8. Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index

    Time frame: Week 4

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 Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2008
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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