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

11 de abril de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

550

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

35 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Vehicle (3 Times/Week)
Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
Droga: Vehicle
Daily for 14 days followed by 3 times per week for 10 weeks
Experimental: 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.
Droga: WC3011 Estradiol Vaginal Cream
Daily for 14 days followed by 3 times per week for 10 weeks
Otros nombres:
  • WC3011

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el inicio en el porcentaje de células superficiales vaginales hasta la evaluación final
Periodo de tiempo: Línea de base (día 0) a evaluación final (hasta la semana 12)
Se recogieron frotis de la pared vaginal de cada participante. Los frotis fueron enviados al laboratorio central para su análisis para determinar el porcentaje de células superficiales. Un cambio positivo desde la línea de base indica una mejora. La evaluación final se define como la última evaluación posterior al inicio disponible.
Línea de base (día 0) a evaluación final (hasta la semana 12)
Cambio desde el inicio en el porcentaje de células parabasales vaginales hasta la evaluación final
Periodo de tiempo: Línea de base (día 0) a evaluación final (hasta la semana 12)
Se recogieron frotis de la pared vaginal de cada participante. Los frotis se enviaron al laboratorio central para su análisis para determinar el porcentaje de células parabasales. Un cambio negativo desde la línea de base indica una mejora. La evaluación final se define como la última evaluación posterior al inicio disponible.
Línea de base (día 0) a evaluación final (hasta la semana 12)
Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Warner Chilcott

Investigadores

  • Director de estudio: Anna Chan, PharmD, Warner Chilcott

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de abril de 2013

Finalización primaria (Actual)

20 de noviembre de 2013

Finalización del estudio (Actual)

20 de noviembre de 2013

Fechas de registro del estudio

Enviado por primera vez

25 de abril de 2013

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2013

Publicado por primera vez (Estimar)

3 de mayo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

11 de abril de 2022

Última verificación

1 de septiembre de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PR-08112

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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