Duration of Effect of Acidform Gel on Vaginal pH
A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
One hundred healthy volunteer women, 20 per each treatment arm, were treated with either Intravaginal Acidform Gel(IVAG), 5 g dose (GROUP A), Acidform gel, 4 g dose (GROUP B), Acidform gel, 3 g dose (GROUP C), Universal Placebo Gel (UPG), 4 g (GROUP D) or no treatment (GROUP E). For GROUPS A, B, C and D, treatment is defined as speculum exam plus instillation of Investigational Product (IP) or placebo gel. For GROUP E (control), no treatment is defined as speculum exam and no gel instillation.
At least 15 women in each group were of either African American or Hispanic ethnicity. Routine screening tests were performed on admission; and subjects assessed for BV via vaginal swabs obtained for grading by Amsel criteria.
A direct vaginal pH reading by research staff- was obtained before the speculum exam, as well as one hour, and six hours post-treatment (Day 0). At the one hour and six hour post treatment time points, the direct vaginal pH readings were taken on specimens collected from two different positions in the vagina, in case of incomplete distribution of the IP soon after administration. Both readings are included as data points. At the six hour timepoint, subjects were trained on self-collecting vaginal swabs and performing the vaginal pH test. At 12 hours post-treatment, subjects performed the vaginal pH test themselves using self-obtained swabs, and record their results for clinician review.
Subjects stayed overnight in the domiciliary unit, and vaginal pH and Amsel criteria was measured again by research staff at 24 (+/- 2) hours post-treatment before discharge on Day 1. The subjects were discharged with the appropriate pH testing supplies and diary. All women agreed to abstain from sexual intercourse, douching and use of any intravaginally applied products or devices until after their final study visit on Day 7.
Subjects measured their vaginal pH at 24 (+/-2) hour intervals for 5 days (Days 2-6) as outpatients and recorded the pH test results, and any change in vaginal comfort, in a provided diary. Subjects also recorded any activities engaged in from the abstinence criteria in the study exclusion list, if applicable, each day. On Day 7, subjects returned to the clinic with their diaries, had their vaginal pH and Amsel criteria determined by the clinic staff, and queried as to any vaginal discomfort (vaginal comfort assessment) over the course of the study, as self-recorded in their diaries.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Bayview Medical Center
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44109
- Metro Health Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy female subjects between 18 and 45 years, inclusive
- Ability to understand the consent process and procedures
- Subjects agree to be available for all study visits
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
- Able and willing to comply with all study procedures
- Have not engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment.
- Agree to abstain from sexual intercourse, douching or any form of vaginal suppository or intravaginal device use during course of study
- Report menstrual cycle regularity (25- to 35- day menstrual cycles)
Exclusion Criteria:
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
- Any other medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment that might interfere with the study
- Family member of the investigation study staff
- Pregnant or breast-feeding
- Inability to provide informed consent
- A subject with a history or expectation of noncompliance with medications or treatment protocol
- Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection (STI) reported or observed during examination, at screening*.
- Women who regularly use douches, vaginal medications or suppositories, feminine sprays, genital wipes or contraceptive spermicides, or report abnormal vaginal discharge in the past 48 hours prior to screening
- Women who are menstruating or who would expect to menstruate during the study
- Women who are currently using contraceptives that are directly delivered to the vaginal mucosa, such as NuvaRing
- Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Acidform Gel, Group A
Administration of a single vaginal dose of Acidform gel (5 g)
|
Effect of 5 g vaginally administered Acidform on pH over 7 days
|
|
Experimental: Acidform Gel, Group B
Administration of a single vaginal dose of Acidform gel (4 g)
|
Effect of 4 g vaginally administered Acidform on pH over 7 days
|
|
Experimental: Acidform Gel, Group C
Administration of a single vaginal dose of Acidform gel (3 g)
|
Effect of 3 g vaginally administered Acidform on pH over 7 days
|
|
Comparador de placebos: Placebo Gel, Group D
Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
|
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
Otros nombres:
|
|
Sin intervención: No intervention, Group E
No vaginal product administered
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Periodo de tiempo: Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.
|
Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment.
The pH of the samples was measured at pre-determined time points over the course of 7 days.
|
Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Effect of a Single Dose of Acidform Gel (3, 4 or 5 g), Placebo Gel (4 g), or no Treatment on Asymptomatic Bacterial Vaginosis (BV) Based on Amsel Criteria.
Periodo de tiempo: Baseline (Day 0), Day 1 and Day 7
|
Amsel Criteria was used at baseline (day 0), compared to Day1 and Day 7 following the single dose of Acidform or placebo.
Amsel criteria assessments consisted of Yes/No indications for the presence of each of the following: Vaginal pH> 4.5; Presence of thin, grayish white vaginal discharge; Positive wet prep; Positive whiff amine test.
Based on the individual criteria, a derived overall result (positive/negative) was reported.
Amsel Result was automatically calculated based whether or not subject is positive in three of the four criteria listed above.
|
Baseline (Day 0), Day 1 and Day 7
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ann Avery, MD, Metro Health Medical Center
- Investigador principal: Seema Nayak, MD, Johns Hopkins University
- Director de estudio: John M Griffiss, MD, Clinical Research Management, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- EVO-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
Ensayos clínicos sobre Acidform 5 g
-
BionovoDesconocidoSíntomas vasomotores | SofocosEstados Unidos
-
Lia BallyUniversity of PadovaTerminadoHipoglucemia posbariátrica | Bypass gástrico en Y de RouxSuiza
-
Region SkaneLund UniversityTerminadoIntolerante a la glucosa
-
University of MinnesotaTerminado
-
Instituto Nacional de Ciencias Medicas y Nutricion...Desconocido
-
Luca RonfaniUniversity of TriesteTerminadoTrastornos del ciclo de la urea, congénitos | Otras enfermedades metabólicasItalia
-
PharmaEssentiaAthenex, Inc.Terminado
-
Scottish Universities Environmental Research CentreBiotechnology and Biological Sciences Research Council; University of GlasgowTerminadoEnvío óptimo de propionato al intestino gruesoReino Unido
-
University of UlsterDunbia, Northern IrelandTerminadoInflamación | Colesterol; Trastorno metabólico | ECVReino Unido
-
HTL-Strefa S.A.Medical University of LodzTerminadoDiabetes Mellitus, Tipo 2 | Diabetes Mellitus, Tipo 1Polonia