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

Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT02670785
Collaborator
(none)
203
Enrollment
20
Locations
4
Arms
9
Actual Duration (Months)
10.2
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Estradiol Vaginal Capsule (EVC)
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
203 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 15, 2016
Actual Primary Completion Date :
Nov 14, 2016
Actual Study Completion Date :
Nov 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Estradiol Vaginal Capsule 0.003 mg

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
Experimental: Estradiol Vaginal Capsule 0.01 mg

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
Experimental: Estradiol Vaginal Capsule 0.02 mg

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
Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Change in the percentage of vaginal superficial cells [Baseline (Week 0) to Final Visit (Week 6)]

  2. Change in the percentage of vaginal parabasal cells [Baseline (Week 0) to Final Visit (Week 6)]

  3. Change in vaginal pH [Baseline (Week 0) to Final Visit (Week 6)]

Secondary Outcome Measures

  1. Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale [Baseline (Week 0) to Final Visit (Week 6)]

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  2. Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom [Baseline (Week 0) to Final Visit (Week 6)]

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  3. Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom [Baseline (Week 0) to Final Visit (Week 6)]

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  4. Change in subject's self-assessment of dysuria [Baseline (Week 0) to Final Visit (Week 6)]

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  5. Change in subject's self-assessment of vaginal and/or vulvar irritation/itching [Baseline (Week 0) to Final Visit (Week 6)]

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  6. Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom [Baseline (Week 0) to Final Visit (Week 6)]

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  7. Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom [Baseline (Week 0) to Final Visit (Week 6)]

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  8. Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding [Baseline (Week 0) to Final Visit (Week 6)]

    Total number of participants who were sexually active assessed if vaginal bleeding was present or absent.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Visions Clinical Research-Tucson Tucson Arizona United States 85712
2 Genesis Center for Clinical Research San Diego California United States 92103
3 Coastal Connecticut Research, LLC New London Connecticut United States 06320
4 Women's Medical Research Group, LLC Clearwater Florida United States 33759
5 Radiant Research, Inc. Pinellas Park Florida United States 33781
6 Comprehensive Clinical Trials, LLC West Palm Beach Florida United States 33409
7 Fellows Research Alliance, Inc Savannah Georgia United States 31406
8 Beyer Research Kalamazoo Michigan United States 49009
9 Office of R. Garn Mabey, M.D. Las Vegas Nevada United States 89128
10 Carolina Women's Research and Wellness Center Durham North Carolina United States 27713
11 Hawthorne Medical Research, Inc. Winston-Salem North Carolina United States 27103
12 Rapid Medical Research, Inc. Cleveland Ohio United States 44122
13 Women's Health Research Columbus Ohio United States 43213
14 Clinical Research of Philadelphia, LLC Philadelphia Pennsylvania United States 19114
15 Fellows Research Alliance, Inc Bluffton South Carolina United States 29910
16 Radiant Research, Inc. Dallas Texas United States 75231
17 Radiant Research, Inc. San Antonio Texas United States 78229
18 Virginia Women's Center Richmond Virginia United States 23233
19 Seattle Women's Health, Research, Gynecology Seattle Washington United States 98105
20 North Spokane Women's Clinic Spokane Washington United States 99207

Sponsors and Collaborators

  • Warner Chilcott

Investigators

  • Study Director: Vilma Sniukiene, MD, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT02670785
Other Study ID Numbers:
  • EVC-MD-01
First Posted:
Feb 2, 2016
Last Update Posted:
Aug 23, 2017
Last Verified:
Aug 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dyspareunia
Atrophy
Estradiol

Study Results

No Results Posted as of Aug 23, 2017