Clinical trial NCT02670785: A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
Official title: A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate Safety and Efficacy of Three Doses of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvovaginal Atrophy
Menopause
Dyspareunia
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 203
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of vulvovaginal atrophy due to post menopause
* Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
* Moderate to severe vaginal dryness
* Normal breast exam; if \> 40 years
* Vaginal pH \> 5.0
* \< 5% superficial cells on vaginal wall cytology smear

Exclusion Criteria:

* Known hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease
* Undiagnosed abnormal genital bleeding
* A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke
* Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events
* Increased frequency/severity headaches with estrogen therapy
* Smokes ≥ 15 cigarettes/day

Primary outcomes:
measure: Change in the percentage of vaginal superficial cells
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in the percentage of vaginal parabasal cells
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in vaginal pH
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
Secondary outcomes:
measure: Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in subject's self-assessment of dysuria
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in subject's self-assessment of vaginal and/or vulvar irritation/itching
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
measure: Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding
timeFrame: Baseline (Week 0) to Final Visit (Week 6)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Visions Clinical Research-Tucson
state: Arizona
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc
state: Georgia
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Las Vegas
country: United States
facility: Office of R. Garn Mabey, M.D.
state: Nevada
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Women's Health Research
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Bluffton
country: United States
facility: Fellows Research Alliance, Inc
state: South Carolina
city: Dallas
country: United States
facility: Radiant Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Richmond
country: United States
facility: Virginia Women's Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Clinic
state: Washington
Study officials:
affiliation: Allergan
name: Vilma Sniukiene, MD
role: STUDY_DIRECTOR
References: