Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
11 avril 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
550
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35211
- Warner Chilcott Investigational Study Site
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Mobile, Alabama, États-Unis, 36608
- Warner Chilcott Investigational Study Site
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Arizona
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Chandler, Arizona, États-Unis, 85224
- Warner Chilcott Investigational Study Site
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Phoenix, Arizona, États-Unis, 85032
- Warner Chilcott Investigational Study Site
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Scottsdale, Arizona, États-Unis, 85251
- Warner Chilcott Investigational Study Site
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Tucson, Arizona, États-Unis, 85712
- Warner Chilcott Investigational Study Site
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Tucson, Arizona, États-Unis, 85710
- Warner Chilcott Investigational Study Site
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California
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Sacramento, California, États-Unis, 95821
- Warner Chilcott Investigational Study Site
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San Diego, California, États-Unis, 92103
- Warner Chilcott Investigational Study Site
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San Diego, California, États-Unis, 92108
- Warner Chilcott Investigational Study Site
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San Diego, California, États-Unis, 92123
- Warner Chilcott Investigational Study Site
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Connecticut
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New London, Connecticut, États-Unis, 06320
- Warner Chilcott Investigational Study Site
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District of Columbia
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Washington, District of Columbia, États-Unis, 20036
- Warner Chilcott Investigational Study Site
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Florida
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Boynton Beach, Florida, États-Unis, 33472
- Warner Chilcott Investigational Study Site
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Clearwater, Florida, États-Unis, 33759
- Warner Chilcott Investigational Study Site
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Jacksonville, Florida, États-Unis, 32216
- Warner Chilcott Investigational Study Site
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Miami, Florida, États-Unis, 33186
- Warner Chilcott Investigational Study Site
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Ormond Beach, Florida, États-Unis, 32174
- Warner Chilcott Investigational Study Site
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Palm Beach Gardens, Florida, États-Unis, 33410
- Warner Chilcott Investigational Study Site
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Pinellas Park, Florida, États-Unis, 33781
- Warner Chilcott Investigational Study Site
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West Palm Beach, Florida, États-Unis, 33409
- Warner Chilcott Investigational Study Site
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Georgia
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Atlanta, Georgia, États-Unis, 30342
- Warner Chilcott Investigational Study Site
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Roswell, Georgia, États-Unis, 30075
- Warner Chilcott Investigational Study Site
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Savannah, Georgia, États-Unis, 31406
- Warner Chilcott Investigational Study Site
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Indiana
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Granger, Indiana, États-Unis, 46530
- Warner Chilcott Investigational Study Site
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Kentucky
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Lexington, Kentucky, États-Unis, 40509
- Warner Chilcott Investigational Study Site
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Louisiana
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Marrero, Louisiana, États-Unis, 70072
- Warner Chilcott Investigational Study Site
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New Orleans, Louisiana, États-Unis, 70115
- Warner Chilcott Investigational Study Site
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Michigan
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Kalamazoo, Michigan, États-Unis, 49009
- Warner Chilcott Investigational Study Site
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Minnesota
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Chaska, Minnesota, États-Unis, 55318
- Warner Chilcott Investigational Study Site
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Nevada
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Las Vegas, Nevada, États-Unis, 89113
- Warner Chilcott Investigational Study Site
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Las Vegas, Nevada, États-Unis, 89128
- Warner Chilcott Investigational Study Site
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New Jersey
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Moorestown, New Jersey, États-Unis, 08057
- Warner Chilcott Investigational Study Site
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North Carolina
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Greensboro, North Carolina, États-Unis, 27408
- Warner Chilcott Investigational Study Site
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New Bern, North Carolina, États-Unis, 28562
- Warner Chilcott Investigational Study Site
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Raleigh, North Carolina, États-Unis, 27607
- Warner Chilcott Investigational Study Site
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Winston-Salem, North Carolina, États-Unis, 27103
- Warner Chilcott Investigational Study Site
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Ohio
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Cincinnati, Ohio, États-Unis, 45249
- Warner Chilcott Investigational Study Site
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Cleveland, Ohio, États-Unis, 44122
- Warner Chilcott Investigational Study Site
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Columbus, Ohio, États-Unis, 43213
- Warner Chilcott Investigational Study Site
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Pennsylvania
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Jenkintown, Pennsylvania, États-Unis, 19046
- Warner Chilcott Investigational Study Site
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Philadelphia, Pennsylvania, États-Unis, 19114
- Warner Chilcott Investigational Study Site
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Pittsburgh, Pennsylvania, États-Unis, 15206
- Warner Chilcott Investigational Study Site
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Rhode Island
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Warwick, Rhode Island, États-Unis, 02886
- Warner Chilcott Investigational Study Site
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South Carolina
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Bluffton, South Carolina, États-Unis, 29910
- Warner Chilcott Investigational Study Site
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Greer, South Carolina, États-Unis, 29650
- Warner Chilcott Investigational Study Site
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Texas
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Austin, Texas, États-Unis, 78759
- Warner Chilcott Investigational Study Site
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Dallas, Texas, États-Unis, 75230
- Warner Chilcott Investigational Study Site
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Dallas, Texas, États-Unis, 75231
- Warner Chilcott Investigational Study Site
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Dallas, Texas, États-Unis, 75234
- Warner Chilcott Investigational Study Site
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Houston, Texas, États-Unis, 77030
- Warner Chilcott Investigational Study Site
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San Antonio, Texas, États-Unis, 78229
- Warner Chilcott Investigational Study Site
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Utah
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South Jordan, Utah, États-Unis, 84095
- Warner Chilcott Investigational Study Site
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Virginia
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Norfolk, Virginia, États-Unis, 23507-1627
- Warner Chilcott Investigational Study Site
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Richmond, Virginia, États-Unis, 23233
- Warner Chilcott Investigational Study Site
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Washington
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Seattle, Washington, États-Unis, 98105
- Warner Chilcott Investigational Study Site
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Spokane, Washington, États-Unis, 99207
- Warner Chilcott Investigational Study Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
35 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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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Expérimental: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Changement du pourcentage initial de cellules superficielles vaginales à l'évaluation finale
Délai: Évaluation initiale (jour 0) à l'évaluation finale (jusqu'à la semaine 12)
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Des frottis de paroi vaginale ont été prélevés sur chaque participante.
Les frottis ont été envoyés au laboratoire central pour analyse afin de déterminer le pourcentage de cellules superficielles.
Un changement positif par rapport au niveau de référence indique une amélioration.
L'évaluation finale est définie comme la dernière évaluation post-baseline disponible.
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Évaluation initiale (jour 0) à l'évaluation finale (jusqu'à la semaine 12)
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Changement du pourcentage de cellules parabasales vaginales entre la valeur initiale et l'évaluation finale
Délai: Évaluation initiale (jour 0) à l'évaluation finale (jusqu'à la semaine 12)
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Des frottis de paroi vaginale ont été prélevés sur chaque participante.
Les frottis ont été envoyés au laboratoire central pour analyse afin de déterminer le pourcentage de cellules parabasales.
Un changement négatif par rapport au niveau de référence indique une amélioration.
L'évaluation finale est définie comme la dernière évaluation post-baseline disponible.
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Évaluation initiale (jour 0) à l'évaluation finale (jusqu'à la semaine 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Anna Chan, PharmD, Warner Chilcott
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 avril 2013
Achèvement primaire (Réel)
20 novembre 2013
Achèvement de l'étude (Réel)
20 novembre 2013
Dates d'inscription aux études
Première soumission
25 avril 2013
Première soumission répondant aux critères de contrôle qualité
29 avril 2013
Première publication (Estimation)
3 mai 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 avril 2022
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PR-08112
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .