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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670785
• Other study ID #: EVC-MD-01
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2016
• Last updated: August 21, 2017
• Start date: February 15, 2016
• Est. completion date: November 14, 2016

Study information

• Verified date: August 2017
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 14, 2016
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Dyspareunia
• Menopause
• Vulvovaginal Atrophy

Intervention

Drug:
• Estradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
• Placebo
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Locations

Country	Name	City	State
United States	Fellows Research Alliance, Inc	Bluffton	South Carolina
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Women's Health Research	Columbus	Ohio
United States	Radiant Research, Inc.	Dallas	Texas
United States	Carolina Women's Research and Wellness Center	Durham	North Carolina
United States	Beyer Research	Kalamazoo	Michigan
United States	Office of R. Garn Mabey, M.D.	Las Vegas	Nevada
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Virginia Women's Center	Richmond	Virginia
United States	Radiant Research, Inc.	San Antonio	Texas
United States	Genesis Center for Clinical Research	San Diego	California
United States	Fellows Research Alliance, Inc	Savannah	Georgia
United States	Seattle Women's Health, Research, Gynecology	Seattle	Washington
United States	North Spokane Women's Clinic	Spokane	Washington
United States	Visions Clinical Research-Tucson	Tucson	Arizona
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the percentage of vaginal superficial cells		Baseline (Week 0) to Final Visit (Week 6)
Primary	Change in the percentage of vaginal parabasal cells		Baseline (Week 0) to Final Visit (Week 6)
Primary	Change in vaginal pH		Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)
Secondary	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.	Baseline (Week 0) to Final Visit (Week 6)