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Duration of Effect of Acidform Gel on Vaginal pH

29. Oktober 2020 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

105

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21224
        • Johns Hopkins Bayview Medical Center
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44109
        • Metro Health Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Acidform Gel, Group A
Administration of a single vaginal dose of Acidform gel (5 g)
Arzneimittel: Acidform 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)
Arzneimittel: Acidform 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)
Arzneimittel: Acidform 3 g
Effect of 3 g vaginally administered Acidform on pH over 7 days
Placebo-Komparator: Placebo Gel, Group D
Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
Arzneimittel: Placebo 4 g
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
Andere Namen:
  • Natrasol 250 HX Pharm
Kein Eingriff: No intervention, Group E
No vaginal product administered

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Evofem Inc.

Mitarbeiter

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

Ermittler

  • Hauptermittler: Ann Avery, MD, Metro Health Medical Center
  • Hauptermittler: Seema Nayak, MD, Johns Hopkins University
  • Studienleiter: John M Griffiss, MD, Clinical Research Management, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. August 2016

Primärer Abschluss (Tatsächlich)

12. Dezember 2016

Studienabschluss (Tatsächlich)

12. Dezember 2016

Studienanmeldedaten

Zuerst eingereicht

18. Februar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Februar 2016

Zuerst gepostet (Schätzen)

26. Februar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. November 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Oktober 2020

Zuletzt verifiziert

1. Oktober 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • EVO-002

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

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