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

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ClinicalTrials.gov Identifier: NCT02670785
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Menopause Dyspareunia Drug: Estradiol Vaginal Capsule (EVC) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : February 15, 2016
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in the percentage of vaginal superficial cells [ Time Frame: Baseline (Week 0) to Final Visit (Week 6) ]
  2. Change in the percentage of vaginal parabasal cells [ Time Frame: Baseline (Week 0) to Final Visit (Week 6) ]
  3. Change in vaginal pH [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (Week 0) to Final Visit (Week 6) ]
    Total number of participants who were sexually active assessed if vaginal bleeding was present or absent.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670785


Locations
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United States, Arizona
Visions Clinical Research-Tucson
Tucson, Arizona, United States, 85712
United States, California
Genesis Center for Clinical Research
San Diego, California, United States, 92103
United States, Connecticut
Coastal Connecticut Research, LLC
New London, Connecticut, United States, 06320
United States, Florida
Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759
Radiant Research, Inc.
Pinellas Park, Florida, United States, 33781
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States, 33409
United States, Georgia
Fellows Research Alliance, Inc
Savannah, Georgia, United States, 31406
United States, Michigan
Beyer Research
Kalamazoo, Michigan, United States, 49009
United States, Nevada
Office of R. Garn Mabey, M.D.
Las Vegas, Nevada, United States, 89128
United States, North Carolina
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States, 27713
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
Women's Health Research
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Fellows Research Alliance, Inc
Bluffton, South Carolina, United States, 29910
United States, Texas
Radiant Research, Inc.
Dallas, Texas, United States, 75231
Radiant Research, Inc.
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Women's Center
Richmond, Virginia, United States, 23233
United States, Washington
Seattle Women's Health, Research, Gynecology
Seattle, Washington, United States, 98105
North Spokane Women's Clinic
Spokane, Washington, United States, 99207
Sponsors and Collaborators
Warner Chilcott
Investigators
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Study Director: Vilma Sniukiene, MD Allergan

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Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT02670785     History of Changes
Other Study ID Numbers: EVC-MD-01
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Dyspareunia
Atrophy
Pathological Conditions, Anatomical
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female