Clinical trial NCT00729469: Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrophy
Vaginal Diseases
Keywords: Vulvar and vaginal atrophy in postmenopausal women
Menopausal symptoms
Vaginal atrophy
Urogenital atrophy
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hormos Medical
name: QuatRx Pharmaceuticals
First posted: 2008-08-07
Enrollment: 919
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)
timeFrame: 4 weeks
measure: Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)
timeFrame: 4 weeks
measure: Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)
timeFrame: 4 weeks
measure: Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
timeFrame: 4 weeks
measure: Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)
timeFrame: 4 weeks
measure: Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
timeFrame: 4 weeks
measure: Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)
timeFrame: 4 weeks
measure: Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.