Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
11. april 2022 oppdatert av: Warner Chilcott
A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
550
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35211
- Warner Chilcott Investigational Study Site
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Mobile, Alabama, Forente stater, 36608
- Warner Chilcott Investigational Study Site
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Warner Chilcott Investigational Study Site
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Phoenix, Arizona, Forente stater, 85032
- Warner Chilcott Investigational Study Site
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Scottsdale, Arizona, Forente stater, 85251
- Warner Chilcott Investigational Study Site
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Tucson, Arizona, Forente stater, 85712
- Warner Chilcott Investigational Study Site
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Tucson, Arizona, Forente stater, 85710
- Warner Chilcott Investigational Study Site
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California
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Sacramento, California, Forente stater, 95821
- Warner Chilcott Investigational Study Site
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San Diego, California, Forente stater, 92103
- Warner Chilcott Investigational Study Site
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San Diego, California, Forente stater, 92108
- Warner Chilcott Investigational Study Site
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San Diego, California, Forente stater, 92123
- Warner Chilcott Investigational Study Site
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Connecticut
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New London, Connecticut, Forente stater, 06320
- Warner Chilcott Investigational Study Site
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District of Columbia
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Washington, District of Columbia, Forente stater, 20036
- Warner Chilcott Investigational Study Site
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Florida
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Boynton Beach, Florida, Forente stater, 33472
- Warner Chilcott Investigational Study Site
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Clearwater, Florida, Forente stater, 33759
- Warner Chilcott Investigational Study Site
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Jacksonville, Florida, Forente stater, 32216
- Warner Chilcott Investigational Study Site
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Miami, Florida, Forente stater, 33186
- Warner Chilcott Investigational Study Site
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Ormond Beach, Florida, Forente stater, 32174
- Warner Chilcott Investigational Study Site
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Palm Beach Gardens, Florida, Forente stater, 33410
- Warner Chilcott Investigational Study Site
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Pinellas Park, Florida, Forente stater, 33781
- Warner Chilcott Investigational Study Site
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West Palm Beach, Florida, Forente stater, 33409
- Warner Chilcott Investigational Study Site
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- Warner Chilcott Investigational Study Site
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Roswell, Georgia, Forente stater, 30075
- Warner Chilcott Investigational Study Site
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Savannah, Georgia, Forente stater, 31406
- Warner Chilcott Investigational Study Site
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Indiana
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Granger, Indiana, Forente stater, 46530
- Warner Chilcott Investigational Study Site
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Kentucky
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Lexington, Kentucky, Forente stater, 40509
- Warner Chilcott Investigational Study Site
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Louisiana
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Marrero, Louisiana, Forente stater, 70072
- Warner Chilcott Investigational Study Site
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New Orleans, Louisiana, Forente stater, 70115
- Warner Chilcott Investigational Study Site
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Michigan
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Kalamazoo, Michigan, Forente stater, 49009
- Warner Chilcott Investigational Study Site
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Minnesota
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Chaska, Minnesota, Forente stater, 55318
- Warner Chilcott Investigational Study Site
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Nevada
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Las Vegas, Nevada, Forente stater, 89113
- Warner Chilcott Investigational Study Site
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Las Vegas, Nevada, Forente stater, 89128
- Warner Chilcott Investigational Study Site
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New Jersey
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Moorestown, New Jersey, Forente stater, 08057
- Warner Chilcott Investigational Study Site
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North Carolina
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Greensboro, North Carolina, Forente stater, 27408
- Warner Chilcott Investigational Study Site
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New Bern, North Carolina, Forente stater, 28562
- Warner Chilcott Investigational Study Site
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Raleigh, North Carolina, Forente stater, 27607
- Warner Chilcott Investigational Study Site
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Winston-Salem, North Carolina, Forente stater, 27103
- Warner Chilcott Investigational Study Site
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Ohio
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Cincinnati, Ohio, Forente stater, 45249
- Warner Chilcott Investigational Study Site
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Cleveland, Ohio, Forente stater, 44122
- Warner Chilcott Investigational Study Site
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Columbus, Ohio, Forente stater, 43213
- Warner Chilcott Investigational Study Site
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Pennsylvania
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Jenkintown, Pennsylvania, Forente stater, 19046
- Warner Chilcott Investigational Study Site
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Philadelphia, Pennsylvania, Forente stater, 19114
- Warner Chilcott Investigational Study Site
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Pittsburgh, Pennsylvania, Forente stater, 15206
- Warner Chilcott Investigational Study Site
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Rhode Island
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Warwick, Rhode Island, Forente stater, 02886
- Warner Chilcott Investigational Study Site
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South Carolina
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Bluffton, South Carolina, Forente stater, 29910
- Warner Chilcott Investigational Study Site
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Greer, South Carolina, Forente stater, 29650
- Warner Chilcott Investigational Study Site
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Texas
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Austin, Texas, Forente stater, 78759
- Warner Chilcott Investigational Study Site
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Dallas, Texas, Forente stater, 75230
- Warner Chilcott Investigational Study Site
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Dallas, Texas, Forente stater, 75231
- Warner Chilcott Investigational Study Site
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Dallas, Texas, Forente stater, 75234
- Warner Chilcott Investigational Study Site
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Houston, Texas, Forente stater, 77030
- Warner Chilcott Investigational Study Site
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San Antonio, Texas, Forente stater, 78229
- Warner Chilcott Investigational Study Site
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Utah
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South Jordan, Utah, Forente stater, 84095
- Warner Chilcott Investigational Study Site
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Virginia
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Norfolk, Virginia, Forente stater, 23507-1627
- Warner Chilcott Investigational Study Site
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Richmond, Virginia, Forente stater, 23233
- Warner Chilcott Investigational Study Site
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Washington
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Seattle, Washington, Forente stater, 98105
- Warner Chilcott Investigational Study Site
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Spokane, Washington, Forente stater, 99207
- Warner Chilcott Investigational Study Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
- Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH >40 mIU/mL
- Age ≥40 years; ≥35 with bilateral oophorectomy
- Vaginal pH >5.0
- Less than or equal to 5% superficial cells on vaginal wall cytologic smear
- Normal clinical breast exam or negative mammogram if ≥ 40 years of age
- Negative urine pregnancy test (non-hysterectomized and <12 months amenorrhea)
Exclusion Criteria:
- Enrollment in Sponsor's Study PR-04409 or PR-05812
- Participation in clinical trial or use of investigational drug within 30 days prior to screening
- Known hypersensitivity to estrogen and/or progestin therapy
- Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
- Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or >50% angiographic narrowing of coronary artery
- Thrombophlebitis or thromboembolic disorder or history of
- Insulin-dependent diabetes mellitus
- Increased frequency or severity of headaches while on hormone or estrogen therapy
- Currently taking St. John's Wort
- Drug/alcohol addiction within past 2 years
- Treatment with anticoagulants (heparin or warfarin)
- Smoking ≥15 cigarettes/day
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Vehicle (3 Times/Week)
Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
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Daily for 14 days followed by 3 times per week for 10 weeks
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Eksperimentell: WC3011 Estradiol Vaginal Cream (3 Times/Week)
WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
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Daily for 14 days followed by 3 times per week for 10 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Endring fra baseline i prosentandelen av vaginale overfladiske celler til endelig vurdering
Tidsramme: Grunnlinje (dag 0) til endelig vurdering (opptil uke 12)
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Vaginale veggutstryk ble samlet inn fra hver deltaker.
Utstrykene ble sendt til sentrallaboratoriet for analyse for å bestemme prosentandelen av overfladiske celler.
En positiv endring fra Baseline indikerer forbedring.
Sluttvurdering er definert som den siste tilgjengelige postbaseline-vurderingen.
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Grunnlinje (dag 0) til endelig vurdering (opptil uke 12)
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Endring fra baseline i prosentandelen av vaginale parabasale celler til endelig vurdering
Tidsramme: Grunnlinje (dag 0) til endelig vurdering (opptil uke 12)
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Vaginale veggutstryk ble samlet inn fra hver deltaker.
Utstrykene ble sendt til sentrallaboratoriet for analyse for å bestemme prosentandelen av parabasale celler.
En negativ endring fra Baseline indikerer bedring.
Sluttvurdering er definert som den siste tilgjengelige postbaseline-vurderingen.
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Grunnlinje (dag 0) til endelig vurdering (opptil uke 12)
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Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Tidsramme: Baseline (Day 0) to final assessment (Up to Week 12)
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Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe.
Higher score indicates the most bothersome symptoms.
A negative change from Baseline indicates improvement.
Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
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Baseline (Day 0) to final assessment (Up to Week 12)
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Change From Baseline in Vaginal pH to Final Assessment
Tidsramme: Baseline (Day 0) to final assessment (Up to Week 12)
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Vaginal pH was obtained at baseline and final visit of the study.
The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14).
A negative change from Baseline indicates improvement.
Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
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Baseline (Day 0) to final assessment (Up to Week 12)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Tidsramme: Baseline to Weeks 2, 4, 8 and 12
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Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe.
Higher score indicates the most bothersome symptoms.
A negative change from Baseline indicates improvement.
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Baseline to Weeks 2, 4, 8 and 12
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Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
Tidsramme: Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
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Self-Assessment of the symptoms of VVA, other than dyspareunia and vaginal bleeding associated with sexual activity, (vaginal and/or vulvar irritation/itching, dysuria and vaginal dryness) were evaluated by a questionnaire.
Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe.
Higher scores indicate the most bothersome symptoms.
A negative change from Baseline indicates improvement.
Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
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Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
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Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
Tidsramme: Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
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Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent".
Number of participants with assessment "present" are reported.
Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
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Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
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Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment
Tidsramme: Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
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Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe.
Higher scores are worse.
A negative change from Baseline indicates improvement.
Final assessment is defined as the last available postbaseline assessment.
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Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
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Change From Baseline in Vaginal pH to Week 12
Tidsramme: Baseline to Week 12
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Vaginal pH was obtained at baseline and final visit of the study.
The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14).
A negative change from Baseline indicates improvement.
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Baseline to Week 12
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Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
Tidsramme: Baseline to Week 12
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Vaginal wall smears were collected from each participant.
The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells.
A positive change from Baseline indicates improvement.
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Baseline to Week 12
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Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
Tidsramme: Baseline to Week 12
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Vaginal wall smears were collected from each participant.
The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells.
A negative change from Baseline indicates improvement.
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Baseline to Week 12
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Anna Chan, PharmD, Warner Chilcott
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. april 2013
Primær fullføring (Faktiske)
20. november 2013
Studiet fullført (Faktiske)
20. november 2013
Datoer for studieregistrering
Først innsendt
25. april 2013
Først innsendt som oppfylte QC-kriteriene
29. april 2013
Først lagt ut (Anslag)
3. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. april 2022
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PR-08112
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .