This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
203
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Visions Clinical Research-Tucson
Tucson, Arizona, United States
Change in the percentage of vaginal superficial cells
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in the percentage of vaginal parabasal cells
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in vaginal pH
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dysuria
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal and/or vulvar irritation/itching
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Genesis Center for Clinical Research
San Diego, California, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Fellows Research Alliance, Inc
Savannah, Georgia, United States
Beyer Research
Kalamazoo, Michigan, United States
Office of R. Garn Mabey, M.D.
Las Vegas, Nevada, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States
...and 10 more locations
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Time frame: Baseline (Week 0) to Final Visit (Week 6)
Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding
Total number of participants who were sexually active assessed if vaginal bleeding was present or absent.
Time frame: Baseline (Week 0) to Final Visit (Week 6)