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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
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 12, 2016
Last Updated
August 21, 2017
Sponsor
Warner Chilcott
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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

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A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

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