Overview

This trial is active, not recruiting.

Conditions vulvovaginal atrophy, menopause, dyspareunia
Treatments estradiol vaginal capsule (evc), placebo
Phase phase 2
Sponsor Warner Chilcott
Start date February 2016
End date November 2016
Trial size 203 participants
Trial identifier NCT02670785, EVC-MD-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
estradiol vaginal capsule (evc)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
(Experimental)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
estradiol vaginal capsule (evc)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
(Experimental)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
estradiol vaginal capsule (evc)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
(Placebo Comparator)
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

Primary Outcomes

Measure
Change in the percentage of vaginal superficial cells
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in the percentage of vaginal parabasal cells
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in vaginal pH
time frame: Baseline (Week 0) to Final Visit (Week 6)

Secondary Outcomes

Measure
Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dysuria
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal and/or vulvar irritation/itching
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom
time frame: Baseline (Week 0) to Final Visit (Week 6)
Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom
time frame: Baseline (Week 0) to Final Visit (Week 6)
Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding
time frame: Baseline (Week 0) to Final Visit (Week 6)

Eligibility Criteria

Female participants at least 35 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Warner Chilcott.