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

11 april 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

550

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

35 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / 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.
Läkemedel: Vehicle
Daily for 14 days followed by 3 times per week for 10 weeks
Experimentell: 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.
Läkemedel: WC3011 Estradiol Vaginal Cream
Daily for 14 days followed by 3 times per week for 10 weeks
Andra namn:
  • WC3011

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ändring från baslinje i procentandelen av vaginala ytliga celler till slutlig bedömning
Tidsram: Baslinje (dag 0) till slutlig bedömning (upp till vecka 12)
Vaginala väggutstryk samlades in från varje deltagare. Utstrykarna skickades till centrallaboratoriet för analys för att bestämma andelen ytliga celler. En positiv förändring från Baseline indikerar förbättring. Slutlig bedömning definieras som den sista tillgängliga postbaseline-bedömningen.
Baslinje (dag 0) till slutlig bedömning (upp till vecka 12)
Ändring från baslinje i procentandelen vaginala parabasala celler till slutlig bedömning
Tidsram: Baslinje (dag 0) till slutlig bedömning (upp till vecka 12)
Vaginala väggutstryk samlades in från varje deltagare. Utstrykarna skickades till centrallaboratoriet för analys för att fastställa andelen parabasala celler. En negativ förändring från Baseline indikerar förbättring. Slutlig bedömning definieras som den sista tillgängliga postbaseline-bedömningen.
Baslinje (dag 0) till slutlig bedömning (upp till vecka 12)
Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Warner Chilcott

Utredare

  • Studierektor: Anna Chan, PharmD, Warner Chilcott

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 april 2013

Primärt slutförande (Faktisk)

20 november 2013

Avslutad studie (Faktisk)

20 november 2013

Studieregistreringsdatum

Först inskickad

25 april 2013

Först inskickad som uppfyllde QC-kriterierna

29 april 2013

Första postat (Uppskatta)

3 maj 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 april 2022

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PR-08112

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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