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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21224
- Johns Hopkins Bayview Medical Center
-
-
Ohio
-
Cleveland, Ohio, Spojené státy, 44109
- Metro Health Medical Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
Experimentální: 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
|
|
Experimentální: 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
|
|
Komparátor placeba: 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
Ostatní jména:
|
|
Žádný zásah: No intervention, Group E
No vaginal product administered
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Časové okno: 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.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Ann Avery, MD, Metro Health Medical Center
- Vrchní vyšetřovatel: Seema Nayak, MD, Johns Hopkins University
- Ředitel studie: John M Griffiss, MD, Clinical Research Management, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- EVO-002
Plán pro data jednotlivých účastníků (IPD)
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