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

Phase 2

Completed

• Conditions: Vulvovaginal Atrophy; Menopause; Dyspareunia
• Interventions: Drug: Estradiol Vaginal Capsule (EVC); Drug: Placebo

• Registration Number: NCT02670785
• Lead Sponsor: Warner Chilcott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-02
• Study Start: 2016-02-15
• Primary Completion: 2016-11-14
• Study Completion: 2016-11-14
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 203

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estradiol Vaginal Capsule 0.01 mg	Estradiol Vaginal Capsule (EVC)	Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule 0.02 mg	Estradiol Vaginal Capsule (EVC)	Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Estradiol Vaginal Capsule 0.003 mg	Estradiol Vaginal Capsule (EVC)	Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Placebo	Placebo	Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in the percentage of vaginal superficial cells	Baseline (Week 0) to Final Visit (Week 6)
Change in the percentage of vaginal parabasal cells	Baseline (Week 0) to Final Visit (Week 6)
Change in vaginal pH	Baseline (Week 0) to Final Visit (Week 6)

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (17)

Rapid Medical Research, Inc.; 🇺🇸 Cleveland, Ohio, United States

Genesis Center for Clinical Research; 🇺🇸 San Diego, California, United States

Seattle Women's Health, Research, Gynecology; 🇺🇸 Seattle, Washington, United States

Women's Medical Research Group, LLC; 🇺🇸 Clearwater, Florida, United States

Radiant Research, Inc.; 🇺🇸 San Antonio, Texas, United States

Comprehensive Clinical Trials, LLC; 🇺🇸 West Palm Beach, Florida, United States

Beyer Research; 🇺🇸 Kalamazoo, Michigan, United States

Office of R. Garn Mabey, M.D.; 🇺🇸 Las Vegas, Nevada, United States

Carolina Women's Research and Wellness Center; 🇺🇸 Durham, North Carolina, United States

Women's Health Research; 🇺🇸 Columbus, Ohio, United States

Clinical Research of Philadelphia, LLC; 🇺🇸 Philadelphia, Pennsylvania, United States

Visions Clinical Research-Tucson; 🇺🇸 Tucson, Arizona, United States

Coastal Connecticut Research, LLC; 🇺🇸 New London, Connecticut, United States

Fellows Research Alliance, Inc; 🇺🇸 Bluffton, South Carolina, United States

Hawthorne Medical Research, Inc.; 🇺🇸 Winston-Salem, North Carolina, United States

Virginia Women's Center; 🇺🇸 Richmond, Virginia, United States

North Spokane Women's Clinic; 🇺🇸 Spokane, Washington, United States