A Phase 2 interventional study of Estradiol Vaginal Capsule (EVC) and Placebo in Vulvovaginal Atrophy, Menopause and Dyspareunia, sponsored by Warner Chilcott. Completed at 20 sites in United States. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by Warner Chilcott · Phase 2, Interventional, and Treatment
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
111 studies on the registry are indexed under Dyspareunia; 33 are open to participants now.
This study's enrollment of 203 is above the median of 60 across 89 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Warner Chilcott is the lead sponsor of 57 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Drug: Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Drug: Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Drug: Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Drug: Placebo
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
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
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)
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Warner Chilcott