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Duration of Effect of Acidform Gel on Vaginal pH

29 ottobre 2020 aggiornato da: Evofem Inc.

A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH

The objective of this study was to determine the magnitude and duration of the reduction in pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH was measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

105

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21224
        • Johns Hopkins Bayview Medical Center
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44109
        • Metro Health Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  1. Healthy female subjects between 18 and 45 years, inclusive
  2. Ability to understand the consent process and procedures
  3. Subjects agree to be available for all study visits
  4. Written informed consent in accordance with institutional guidelines
  5. Negative pregnancy test
  6. Able and willing to comply with all study procedures
  7. Have not engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment.
  8. Agree to abstain from sexual intercourse, douching or any form of vaginal suppository or intravaginal device use during course of study
  9. Report menstrual cycle regularity (25- to 35- day menstrual cycles)

Exclusion Criteria:

  1. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
  2. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
  3. 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
  4. Family member of the investigation study staff
  5. Pregnant or breast-feeding
  6. Inability to provide informed consent
  7. A subject with a history or expectation of noncompliance with medications or treatment protocol
  8. Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection (STI) reported or observed during examination, at screening*.
  9. 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
  10. Women who are menstruating or who would expect to menstruate during the study
  11. Women who are currently using contraceptives that are directly delivered to the vaginal mucosa, such as NuvaRing
  12. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Acidform Gel, Group A
Administration of a single vaginal dose of Acidform gel (5 g)
Droga: Acidform 5 g
Effect of 5 g vaginally administered Acidform on pH over 7 days
Sperimentale: Acidform Gel, Group B
Administration of a single vaginal dose of Acidform gel (4 g)
Droga: Acidform 4 g
Effect of 4 g vaginally administered Acidform on pH over 7 days
Sperimentale: Acidform Gel, Group C
Administration of a single vaginal dose of Acidform gel (3 g)
Droga: Acidform 3 g
Effect of 3 g vaginally administered Acidform on pH over 7 days
Comparatore placebo: Placebo Gel, Group D
Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
Droga: Placebo 4 g
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
Altri nomi:
  • Natrasol 250 HX Pharm
Nessun intervento: No intervention, Group E
No vaginal product administered

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Evofem Inc.

Collaboratori

Johns Hopkins University
MetroHealth Medical Center
Clinical Research Management, Inc.

Investigatori

  • Investigatore principale: Ann Avery, MD, Metro Health Medical Center
  • Investigatore principale: Seema Nayak, MD, Johns Hopkins University
  • Direttore dello studio: John M Griffiss, MD, Clinical Research Management, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 agosto 2016

Completamento primario (Effettivo)

12 dicembre 2016

Completamento dello studio (Effettivo)

12 dicembre 2016

Date di iscrizione allo studio

Primo inviato

18 febbraio 2016

Primo inviato che soddisfa i criteri di controllo qualità

25 febbraio 2016

Primo Inserito (Stima)

26 febbraio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2020

Ultimo verificato

1 ottobre 2020

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • EVO-002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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