A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
Primary Purpose
Vulvovaginal Atrophy, Menopause, Dyspareunia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Estradiol Vaginal Capsule (EVC)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Visions Clinical Research-Tucson
- Genesis Center for Clinical Research
- Coastal Connecticut Research, LLC
- Women's Medical Research Group, LLC
- Radiant Research, Inc.
- Comprehensive Clinical Trials, LLC
- Fellows Research Alliance, Inc
- Beyer Research
- Office of R. Garn Mabey, M.D.
- Carolina Women's Research and Wellness Center
- Hawthorne Medical Research, Inc.
- Rapid Medical Research, Inc.
- Women's Health Research
- Clinical Research of Philadelphia, LLC
- Fellows Research Alliance, Inc
- Radiant Research, Inc.
- Radiant Research, Inc.
- Virginia Women's Center
- Seattle Women's Health, Research, Gynecology
- North Spokane Women's Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Estradiol Vaginal Capsule 0.003 mg
Estradiol Vaginal Capsule 0.01 mg
Estradiol Vaginal Capsule 0.02 mg
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in the percentage of vaginal superficial cells
Change in the percentage of vaginal parabasal cells
Change in vaginal pH
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02670785
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
November 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy, Menopause, Dyspareunia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Estradiol Vaginal Capsule 0.003 mg
Arm Type
Experimental
Arm Description
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Arm Title
Estradiol Vaginal Capsule 0.01 mg
Arm Type
Experimental
Arm Description
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Arm Title
Estradiol Vaginal Capsule 0.02 mg
Arm Type
Experimental
Arm Description
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Estradiol Vaginal Capsule (EVC)
Intervention Description
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Primary Outcome Measure Information:
Title
Change in the percentage of vaginal superficial cells
Time Frame
Baseline (Week 0) to Final Visit (Week 6)
Title
Change in the percentage of vaginal parabasal cells
Time Frame
Baseline (Week 0) to Final Visit (Week 6)
Title
Change in vaginal pH
Time Frame
Baseline (Week 0) to Final Visit (Week 6)
Secondary Outcome Measure Information:
Title
Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale
Description
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)
Title
Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom
Description
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)
Title
Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom
Description
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)
Title
Change in subject's self-assessment of dysuria
Description
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)
Title
Change in subject's self-assessment of vaginal and/or vulvar irritation/itching
Description
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)
Title
Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom
Description
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)
Title
Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom
Description
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)
Title
Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding
Description
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Sniukiene, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Visions Clinical Research-Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Radiant Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Fellows Research Alliance, Inc
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Office of R. Garn Mabey, M.D.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Carolina Women's Research and Wellness Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Women's Health Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Fellows Research Alliance, Inc
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Radiant Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Women's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Seattle Women's Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Women's Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
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