Vulvovaginal AtrophyPhase 2NCT02670785
A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
A Phase 2 study testing Estradiol Vaginal Capsule (EVC) in people with Vulvovaginal Atrophy and Menopause, run by Warner Chilcott at 20 sites in United States.
Trial summary
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Vulvovaginal Atrophy, Menopause, Dyspareunia
- What is being tested?
- Estradiol Vaginal Capsule (EVC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 20 sitesUnited States
- Study dates
- 15 Feb 2016to 14 Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Fellows Research Alliance, Inc
Bluffton, South Carolina, 29910
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Women's Health Research
Columbus, Ohio, 43213
Radiant Research, Inc.
Dallas, Texas, 75231
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
Beyer Research
Kalamazoo, Michigan, 49009
Office of R. Garn Mabey, M.D.
Las Vegas, Nevada, 89128
Coastal Connecticut Research, LLC
New London, Connecticut, 06320
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Radiant Research, Inc.
Pinellas Park, Florida, 33781
Virginia Women's Center
Richmond, Virginia, 23233
Radiant Research, Inc.
San Antonio, Texas, 78229
Genesis Center for Clinical Research
San Diego, California, 92103
Fellows Research Alliance, Inc
Savannah, Georgia, 31406
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105
North Spokane Women's Clinic
Spokane, Washington, 99207
Visions Clinical Research-Tucson
Tucson, Arizona, 85712
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
About this study
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
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia
- Being tested
- Estradiol Vaginal Capsule (EVC), Placebo
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol Vaginal Capsule (EVC)Drug
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
PlaceboDrug
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Estradiol Vaginal Capsule 0.003 mg | Experimental | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks Receives: Drug: Estradiol Vaginal Capsule (EVC) |
| Estradiol Vaginal Capsule 0.01 mg | Experimental | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks Receives: Drug: Estradiol Vaginal Capsule (EVC) |
| Estradiol Vaginal Capsule 0.02 mg | Experimental | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks Receives: Drug: Estradiol Vaginal Capsule (EVC) |
| Placebo | Placebo comparator | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of vaginal superficial cells
Measured: Baseline (Week 0) to Final Visit (Week 6)
Change in the percentage of vaginal parabasal cells
Measured: Baseline (Week 0) to Final Visit (Week 6)
Change in vaginal pH
Measured: Baseline (Week 0) to Final Visit (Week 6)
Secondary outcomes (8)
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.
Measured: Baseline (Week 0) to Final Visit (Week 6)
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.
Measured: Baseline (Week 0) to Final Visit (Week 6)
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.
Measured: Baseline (Week 0) to Final Visit (Week 6)
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.
Measured: Baseline (Week 0) to Final Visit (Week 6)
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.
Measured: 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
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Measured: 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
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.
Measured: Baseline (Week 0) to Final Visit (Week 6)
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.
Measured: Baseline (Week 0) to Final Visit (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start15 Feb 2016
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vilma Sniukiene, MD, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670785
- Sponsor's protocol ID
- EVC-MD-01
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02670785
- Acronym / sponsor ID
- EVC-MD-01
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Estradiol Vaginal Capsule 0.003 mg | Experimental | Drug: Estradiol Vaginal Capsule (EVC)Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
| Estradiol Vaginal Capsule 0.01 mg | Experimental | Drug: Estradiol Vaginal Capsule (EVC)Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
| Estradiol Vaginal Capsule 0.02 mg | Experimental | Drug: Estradiol Vaginal Capsule (EVC)Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboAdministered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol Vaginal Capsule (EVC)Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks | Drug | Estradiol Vaginal Capsule 0.003 mg, Estradiol Vaginal Capsule 0.01 mg, Estradiol Vaginal Capsule 0.02 mg |
| PlaceboAdministered intravaginally once daily for 2 weeks and then once weekly for 4 weeks | Drug | Placebo |
Primary outcome
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)
8 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilma Sniukiene, MD study director
Allergan
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estradiol Vaginal Capsule (EVC) in people with Vulvovaginal Atrophy and Menopause, run by Warner Chilcott at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percentage of vaginal superficial cells (time frame: Baseline (Week 0) to Final Visit (Week 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.