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

Atrophy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729469
• Other study ID #: 15-50821
• Status: Completed
• Phase: Phase 3
• Start date: July 2008
• Est. completion date: August 2009

Study information

• Verified date: April 2018
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 919
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Diseases

Intervention

Drug:
• Ospemifene 60 mg
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
• Placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shionogi	Hormos Medical, QuatRx Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)		12 weeks
Primary	Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)		12 weeks
Primary	Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)		12 weeks
Primary	Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)		12 weeks
Primary	Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)		12 weeks
Primary	Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)		12 weeks
Primary	Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)		12 weeks
Primary	Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)		12 weeks
Secondary	Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)		4 weeks
Secondary	Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)		4 weeks
Secondary	Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)		4 weeks
Secondary	Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)		4 weeks
Secondary	Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)		4 weeks
Secondary	Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)		4 weeks
Secondary	Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)		4 weeks
Secondary	Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)		4 weeks