Clinical trial NCT01283555: Comparative Safety Study of Two Vaginal Applicators With Tenofovir
Official title: Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbicide Applicator
Keywords: Microbicide, Applicator, Safety
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: CONRAD
name: Profamilia, Santo Domingo, DR
First posted: 2011-01-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to compare the effect of two vaginal applicators, delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily use.

The secondary objectives are to:

1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir.
2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18 to 50, inclusive
* Pre-menopausal
* In good health as reported by individual
* Have regular menstrual cycles (24 to 35 days)
* Low risk for sexually transmitted infections (only one sexual partner in the last three months)
* Not pregnant or at risk of pregnancy (must either have had a tubal ligation, or currently be using a hormonal method of contraception)
* Negative on a urine pregnancy test
* Willing to abstain from sexual intercourse and masturbation during two 7-day periods when applicators are being used
* Willing to abstain from use of vaginal products during course of study (including douching, use of vaginal applicators for medication, lubrication, sex toys, other)
* Willing to follow procedural requirements of study
* Willing and able to provide informed consent for study participation
* Willing to provide investigator with phone number or address where she can be reached during the study

Exclusion Criteria:

* History of hysterectomy
* Pregnancy or within two months of last pregnancy outcome (delivery, spontaneous or induced abortion, medical or surgical management of ectopic pregnancy)
* Post-menopausal
* Breastfeeding
* Use of an intra-uterine device (IUD), cervical caps or diaphragm for contraceptive purposes
* Diagnosis or treatment for a sexually transmitted disease within the past 30 days;
* More than one sexual partner in the last 3 months
* Has had surgery on the external genitalia, vagina, or cervix within the past 3 months;
* Current or past use of any anti-retroviral therapies including but not limited to systemic Tenofovir (Viread®)
* Current or anticipated use of drugs on a daily basis that may reduce renal function (e.g. acyclovir or ibuprofen) or liver function (e.g. Tylenol)
* HIV positive at time of screening
* Hepatitis B surface antigen (HBsAg) positive at time of screening
* Positive test results for Neisseria gonorrhea, Chlamydia trachomatis, or Trichomonas vaginalis at time of screening.
* At baseline colposcopic exam (Visit 2), findings involving disruption of epithelium with disruption of blood vessels or deep disruption of epithelium alone. Any area of epithelium with bleeding will be considered deeply disrupted.
* Any abnormal finding on colposcopic exams which in the opinion of the investigator, precludes participation in the study
* At baseline exams, clinical symptoms or signs of vaginitis or vulvitis confirmed by a wet mount exam of the discharge. Note: If vaginitis or vulvitis is present at either baseline exam (visits 2 or 10), volunteer will be treated and rescheduled for new baseline exam one week after application of last treatment dose. If signs or symptoms are still present at the rescheduled baseline exam for Visit 2, the volunteer will not be enrolled into study. If signs or symptoms are still present at the rescheduled baseline exam for Visit 10, the volunteer will be discontinued from the study.
* Serum chemistry (glucose, creatinine, bilirubin, AST \[aspartate aminotransferase\] and ALT \[alanine transaminase\]) not within normal expected levels according to the specifications of the local laboratory.
* Hemoglobin, hematocrit and total white blood cell not within 15 % of lower and upper limit normal levels according to the specifications of the local laboratory.
* Participation in any other research study in the 30 days prior to screening and/or plans to participate in any other research study during the entire study duration.

Primary outcomes:
measure: Number of Colposcopic Findings (Baseline and After One Week of Product Use)
timeFrame: 7 days
Secondary outcomes:
measure: Filled Volume
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Filling Precision (5% Range)
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Filling Precision (10% Range)
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Filling Accuracy (% of Target Dose)
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Dosing Volume (Expressed Volume)
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Dosing Precision, 5% (Expressed Volume)
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Dosing Precision, 10% (Expressed Volume)
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Dosing Accuracy (% of Target Dose Delivered)
timeFrame: 3 dose delivery measurements during 1 week of product use
measure: Number of Participants Reporting Applicator Easy to Fill
timeFrame: Final study visit (after completing both study arms)
measure: Number of Respondents Reporting Confidence With Filling the User-filled Applicator
timeFrame: Final study visit (after completing both study arms)
measure: Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting Applicator Easy to Insert
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That the Gel Was Easy to Dispense
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That Applicator Was Comfortable to Use
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That the Instructions for Use Were Helpful
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That Both Applicators Were Acceptable
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
timeFrame: Final study visit (after completing both study arms)
measure: Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention
timeFrame: Final study visit (after completing both study arms)
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Clinica Profamilia
Study officials:
affiliation: Profamilia
name: Vivian Brache
role: PRINCIPAL_INVESTIGATOR
References: