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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Show Show 20 study locations
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    
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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Dyspareunia
Atrophy
Pathological Conditions, Anatomical
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs