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Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia

11. april 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

550

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35211
        • Warner Chilcott Investigational Study Site
      • Mobile, Alabama, Forenede Stater, 36608
        • Warner Chilcott Investigational Study Site
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Warner Chilcott Investigational Study Site
      • Phoenix, Arizona, Forenede Stater, 85032
        • Warner Chilcott Investigational Study Site
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Warner Chilcott Investigational Study Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Warner Chilcott Investigational Study Site
      • Tucson, Arizona, Forenede Stater, 85710
        • Warner Chilcott Investigational Study Site
    • California
      • Sacramento, California, Forenede Stater, 95821
        • Warner Chilcott Investigational Study Site
      • San Diego, California, Forenede Stater, 92103
        • Warner Chilcott Investigational Study Site
      • San Diego, California, Forenede Stater, 92108
        • Warner Chilcott Investigational Study Site
      • San Diego, California, Forenede Stater, 92123
        • Warner Chilcott Investigational Study Site
    • Connecticut
      • New London, Connecticut, Forenede Stater, 06320
        • Warner Chilcott Investigational Study Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20036
        • Warner Chilcott Investigational Study Site
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Warner Chilcott Investigational Study Site
      • Clearwater, Florida, Forenede Stater, 33759
        • Warner Chilcott Investigational Study Site
      • Jacksonville, Florida, Forenede Stater, 32216
        • Warner Chilcott Investigational Study Site
      • Miami, Florida, Forenede Stater, 33186
        • Warner Chilcott Investigational Study Site
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Warner Chilcott Investigational Study Site
      • Palm Beach Gardens, Florida, Forenede Stater, 33410
        • Warner Chilcott Investigational Study Site
      • Pinellas Park, Florida, Forenede Stater, 33781
        • Warner Chilcott Investigational Study Site
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Warner Chilcott Investigational Study Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Warner Chilcott Investigational Study Site
      • Roswell, Georgia, Forenede Stater, 30075
        • Warner Chilcott Investigational Study Site
      • Savannah, Georgia, Forenede Stater, 31406
        • Warner Chilcott Investigational Study Site
    • Indiana
      • Granger, Indiana, Forenede Stater, 46530
        • Warner Chilcott Investigational Study Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Warner Chilcott Investigational Study Site
    • Louisiana
      • Marrero, Louisiana, Forenede Stater, 70072
        • Warner Chilcott Investigational Study Site
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Warner Chilcott Investigational Study Site
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Warner Chilcott Investigational Study Site
    • Minnesota
      • Chaska, Minnesota, Forenede Stater, 55318
        • Warner Chilcott Investigational Study Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89113
        • Warner Chilcott Investigational Study Site
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Warner Chilcott Investigational Study Site
    • New Jersey
      • Moorestown, New Jersey, Forenede Stater, 08057
        • Warner Chilcott Investigational Study Site
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27408
        • Warner Chilcott Investigational Study Site
      • New Bern, North Carolina, Forenede Stater, 28562
        • Warner Chilcott Investigational Study Site
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Warner Chilcott Investigational Study Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Warner Chilcott Investigational Study Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45249
        • Warner Chilcott Investigational Study Site
      • Cleveland, Ohio, Forenede Stater, 44122
        • Warner Chilcott Investigational Study Site
      • Columbus, Ohio, Forenede Stater, 43213
        • Warner Chilcott Investigational Study Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, Forenede Stater, 19046
        • Warner Chilcott Investigational Study Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Warner Chilcott Investigational Study Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
        • Warner Chilcott Investigational Study Site
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Warner Chilcott Investigational Study Site
    • South Carolina
      • Bluffton, South Carolina, Forenede Stater, 29910
        • Warner Chilcott Investigational Study Site
      • Greer, South Carolina, Forenede Stater, 29650
        • Warner Chilcott Investigational Study Site
    • Texas
      • Austin, Texas, Forenede Stater, 78759
        • Warner Chilcott Investigational Study Site
      • Dallas, Texas, Forenede Stater, 75230
        • Warner Chilcott Investigational Study Site
      • Dallas, Texas, Forenede Stater, 75231
        • Warner Chilcott Investigational Study Site
      • Dallas, Texas, Forenede Stater, 75234
        • Warner Chilcott Investigational Study Site
      • Houston, Texas, Forenede Stater, 77030
        • Warner Chilcott Investigational Study Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Warner Chilcott Investigational Study Site
    • Utah
      • South Jordan, Utah, Forenede Stater, 84095
        • Warner Chilcott Investigational Study Site
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507-1627
        • Warner Chilcott Investigational Study Site
      • Richmond, Virginia, Forenede Stater, 23233
        • Warner Chilcott Investigational Study Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Warner Chilcott Investigational Study Site
      • Spokane, Washington, Forenede Stater, 99207
        • Warner Chilcott Investigational Study Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Medicin: Vehicle
Daily for 14 days followed by 3 times per week for 10 weeks
Eksperimentel: 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.
Medicin: WC3011 Estradiol Vaginal Cream
Daily for 14 days followed by 3 times per week for 10 weeks
Andre navne:
  • WC3011

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i procentdelen af ​​vaginale overfladiske celler til endelig vurdering
Tidsramme: Baseline (dag 0) til endelig vurdering (op til uge 12)
Vaginale vægudstrygninger blev indsamlet fra hver deltager. Udstrygningerne blev sendt til det centrale laboratorium til analyse for at bestemme procentdelen af ​​overfladiske celler. En positiv ændring fra baseline indikerer forbedring. Endelig vurdering er defineret som den sidste tilgængelige postbaseline vurdering.
Baseline (dag 0) til endelig vurdering (op til uge 12)
Ændring fra baseline i procentdelen af ​​vaginale parabasale celler til endelig vurdering
Tidsramme: Baseline (dag 0) til endelig vurdering (op til uge 12)
Vaginale vægudstrygninger blev indsamlet fra hver deltager. Udstrygningerne blev sendt til det centrale laboratorium til analyse for at bestemme procentdelen af ​​parabasale celler. En negativ ændring fra baseline indikerer forbedring. Endelig vurdering er defineret som den sidste tilgængelige postbaseline vurdering.
Baseline (dag 0) til endelig vurdering (op til uge 12)
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)
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.
Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Final Assessment
Tidsramme: Baseline (Day 0) to final assessment (Up to Week 12)
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.
Baseline (Day 0) to final assessment (Up to Week 12)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
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.
Baseline to Weeks 2, 4, 8 and 12
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)
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.
Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
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)
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.
Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
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)
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.
Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Week 12
Tidsramme: Baseline to Week 12
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.
Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
Tidsramme: Baseline to Week 12
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.
Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
Tidsramme: Baseline to Week 12
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.
Baseline to Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Warner Chilcott

Efterforskere

  • Studieleder: Anna Chan, PharmD, Warner Chilcott

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. april 2013

Primær færdiggørelse (Faktiske)

20. november 2013

Studieafslutning (Faktiske)

20. november 2013

Datoer for studieregistrering

Først indsendt

25. april 2013

Først indsendt, der opfyldte QC-kriterier

29. april 2013

Først opslået (Skøn)

3. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2022

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PR-08112

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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