Microbicide ApplicatorNCT01283555
Comparative Safety Study of Two Vaginal Applicators With Tenofovir
A study testing Tenofovir in people with Microbicide Applicator, run by PATH at 1 site in Dominican Republic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbicide Applicator
- What is being tested?
- Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jan 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir
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:
- Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir.
- Compare the acceptability of the user-filled applicator with the pre-filled applicator.
- Conditions
- Microbicide Applicator
- Being tested
- Tenofovir
- Keywords
- Microbicide, Applicator, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Also called TFV
Delivered using prefilled and user-filled applicator
| Study group | Role | What they receive |
|---|---|---|
| User-Filled Applicator | Experimental | Not described Receives: Drug: Tenofovir |
| Prefilled applicator | Other | Not described Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Colposcopic Findings (Baseline and After One Week of Product Use)
Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator
Measured: 7 days
Secondary outcomes (22)
Filled Volume
At each dose delivery visit, the applicator was weighed, prior to vaginal insertion. For the user-filled applicator, the participant handed the applicator to the investigator after filling with gel from the multidose tube. The applicator was then weighed and returned to the participant for insertion. For the prefilled applicator, the participant inserted the plunger into the barrel, and then handed the applicator to the investigator for weighing.
Measured: 3 dose delivery measurements during 1 week of product use
Filling Precision (5% Range)
A 5% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-5% of average volume)
Measured: 3 dose delivery measurements during 1 week of product use
Filling Precision (10% Range)
A 10% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-10% of average volume)
Measured: 3 dose delivery measurements during 1 week of product use
Filling Accuracy (% of Target Dose)
The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The filled volume for each applicator was compared with the intended target dose of 4.0ml.
Measured: 3 dose delivery measurements during 1 week of product use
Dosing Volume (Expressed Volume)
At each dose delivery visit, the applicator was weighed prior to vaginal insertion and after use. The volume of gel expressed was measured using the following data: weight of filled applicator, weight of emptied applicator, the average weight of an empty applicator, and gel density.
Measured: 3 dose delivery measurements during 1 week of product use
Dosing Precision, 5% (Expressed Volume)
A 5% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-5% of average volume)
Measured: 3 dose delivery measurements during 1 week of product use
Dosing Precision, 10% (Expressed Volume)
A 10% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-10% of average volume)
Measured: 3 dose delivery measurements during 1 week of product use
Dosing Accuracy (% of Target Dose Delivered)
The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The average dose delivered for each applicator was compared with the intended target dose of 4.0ml.
Measured: 3 dose delivery measurements during 1 week of product use
Number of Participants Reporting Applicator Easy to Fill
Participants were asked to describe the process of filling the user-filled applicator.
Response categories included "easy", "moderately difficult", and "difficult".
Since "ease of filling" only applies to the user-filled applicator, this question was not applicable for the prefilled applicator.
Measured: Final study visit (after completing both study arms)
Number of Respondents Reporting Confidence With Filling the User-filled Applicator
Participants were asked when using the user-filled applicator, how confident did they feel that they at inserted the correct amount of gel into the applicator.
Response categories included "very confident", "confident", and "not confident".
(Note: this question does not apply to the prefilled applicator.)
Measured: Final study visit (after completing both study arms)
Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly
Participants were asked how did they know when the applicator was filled correctly (that is, with the right amount of gel). More than one answer was allowed.
Response categories included "plunger automatically stopped", "the 'FULL' line was reached", and "other".
Note: this question does not apply to the prefilled applicator.
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting Applicator Easy to Insert
Participants were asked to describe the insertion of the applicator into the vagina for each applicator (user-filled and prefilled).
Response categories included "easy", "moderately difficult", and "difficult".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting That the Gel Was Easy to Dispense
Participants were asked to describe the dispensing of the gel into the vagina with each applicator (user-filled and prefilled).
Response categories included "easy", "moderately difficult", and "difficult".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors
Participants were asked about their preference for either the user-filled or prefilled applicator with regard to several use factors as well as in relation to disposal, storage, and overall comfort and preference.
Response categories included "user-filled", "prefilled", and "same".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting That Applicator Was Comfortable to Use
Participants were asked to describe the comfort of use for each applicator type(user-filled and prefilled).
Response categories included "comfortable", "neutral", and "uncomfortable".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort
Participants were asked if they could suggest ways that would make each applicator easier or more comfortable to use. Response categories were "yes" and "no". If yes, participants were asked to describe how they would make the applicator easier and/or more comfortable to use.
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting That the Instructions for Use Were Helpful
For each applicator type, participants were asked if the instructions were helpful to you.
Response categories were "yes" and "no".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting That Both Applicators Were Acceptable
Participants were asked if both applicators were acceptable to them. Responses were either "yes" or "no".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator
Participants were asked if the cost of the applicator would influence their choice of applicator.
Response categories were "yes", "no", and "maybe".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
Participants were asked if they would use the user-filled applicator in the future if it came with a gel that helped prevent HIV infection.
Response categories included "yes", "no", and "in some circumstances".
Measured: Final study visit (after completing both study arms)
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
Participants were asked if there were any reasons that they would not want to use this user-filled applicator in the future if it came with a gel that helped prevent HIV infection.
Response categories included "yes", "no", and "in some circumstances".
Measured: Final study visit (after completing both study arms)
Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention
Participants were asked if they would recommend the user-filled applicator to other women if it came with a gel that helped prevent HIV infection.
Response categories included "yes", "no", and "in some circumstances".
Measured: Final study visit (after completing both study arms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Microbicide ApplicatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- CONRAD, Profamilia, Santo Domingo, DR
- Responsible party
- Sponsor
- Investigators
- Vivian Brache, Principal investigator, Profamilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283555
- Sponsor's protocol ID
- PATH HS-522
- Status last verified
- Jun 2012
- First submitted
- 24 Jan 2011
- Last updated
- 16 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir
- ClinicalTrials.gov ID
- NCT01283555
- Acronym / sponsor ID
- PATH HS-522
- Conditions
- Microbicide Applicator
- Keywords
- Microbicide, Applicator, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- CONRAD, Profamilia, Santo Domingo, DR
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Posted 22 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir.
- Compare the acceptability of the user-filled applicator with the pre-filled applicator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| User-Filled Applicator | Experimental | Drug: Tenofovir |
| Prefilled applicator | Other | Drug: Tenofovir |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Female
- Age 18 to 50, inclusive
- Pre-menopausal
- In good health as reported by individual
- Have regular menstrual cycles (24 to 35 days)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenofovirAlso: TFVDelivered using prefilled and user-filled applicator | Drug | Prefilled applicator, User-Filled Applicator |
Primary outcome
Number of Colposcopic Findings (Baseline and After One Week of Product Use)
Time frame: 7 days
Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator
22 secondary outcomes
Filled Volume
Time frame: 3 dose delivery measurements during 1 week of product use
Filling Precision (5% Range)
Time frame: 3 dose delivery measurements during 1 week of product use
Filling Precision (10% Range)
Time frame: 3 dose delivery measurements during 1 week of product use
Filling Accuracy (% of Target Dose)
Time frame: 3 dose delivery measurements during 1 week of product use
Dosing Volume (Expressed Volume)
Time frame: 3 dose delivery measurements during 1 week of product use
Dosing Precision, 5% (Expressed Volume)
Time frame: 3 dose delivery measurements during 1 week of product use
Dosing Precision, 10% (Expressed Volume)
Time frame: 3 dose delivery measurements during 1 week of product use
Dosing Accuracy (% of Target Dose Delivered)
Time frame: 3 dose delivery measurements during 1 week of product use
Number of Participants Reporting Applicator Easy to Fill
Time frame: Final study visit (after completing both study arms)
Number of Respondents Reporting Confidence With Filling the User-filled Applicator
Time frame: Final study visit (after completing both study arms)
Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting Applicator Easy to Insert
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting That the Gel Was Easy to Dispense
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting That Applicator Was Comfortable to Use
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting That the Instructions for Use Were Helpful
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting That Both Applicators Were Acceptable
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
Time frame: Final study visit (after completing both study arms)
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
Time frame: Final study visit (after completing both study arms)
Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention
Time frame: Final study visit (after completing both study arms)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian Brache principal investigator
Profamilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir in people with Microbicide Applicator, run by PATH at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Colposcopic Findings (Baseline and After One Week of Product Use) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012; AzTrials last refreshed its copy on 6 Nov 2026.