Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CONRAD | OTHER |
| Profamilia, Santo Domingo, DR | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| User-Filled Applicator | Experimental |
| |
| Prefilled applicator | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir | Drug | Delivered using prefilled and user-filled applicator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivian Brache | Profamilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Profamilia | Santo Domingo | 10401 | Dominican Republic |
25 were enrolled in this study which used a cross-over design. Participants were randomized to order of applicator use.
Recruitment began on 26 January 2011 and ended on 10 March 2011. Recruitment was done at Clinica Profamilia, Santo Domingo, Dominican Republic. Healthy women, 18 to 50 years of age (inclusive), who attended the clinic for health care, who were not at risk for pregnancy, and at low risk of sexually transmitted infection were informed of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | User-Filled Applicator First, Then Prefilled | User-filled paper applicator (filled using a tube of Tenofovir 1% gel)used twice daily in first intervention period and prefilled applicator used twice daily in second intervention period (after washout period) |
| FG001 | Prefilled Applicator First, Then User-filled | Plastic applicator (prefilled with Tenofovir 1% gel) used twice daily in first intervention period and user-filled applicator used twice daily in second intervention period (after washout period) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period of at Least 21 Days |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to use the prefilled applicator first and the user-filled applicator first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Per protocol all participants were included in the analysis. | Posted | Mean | Standard Deviation | ml | 3 dose delivery measurements during 1 week of product use | filled volume | Participants |
|
6 months
Adverse events were collected for the entire study period: January 26, 2011, to June 10, 2011.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | User-Filled Applicator | paper applicator (filled using a tube of Tenofovir 1% gel) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
Due to an error in the interpretation of the user instructions and resulting depth of plunger insertion into the barrel by the participants, the dose delivery data for the prefilled applicator were not valid.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Cohen | PATH | 206-285-3500 | jcohen@path.org |
Not provided
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) | 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) | 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. | 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. | 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) | 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) | 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. | 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. | 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.) | 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. | 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". | 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". | 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". | 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". | 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. | 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". | 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". | 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". | 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". | 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". | 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". | Final study visit (after completing both study arms) |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prefilled Applicator |
plastic applicator (prefilled with Tenofovir 1% gel) |
|
|
| Secondary | 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) | Per protocol all participants were included in the analysis. | Posted | Number | doses | 3 dose delivery measurements during 1 week of product use | volume of filled applicator | Participants |
|
|
|
| Secondary | 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) | Per protocol all participants were included in the analysis. | Posted | Number | doses | 3 dose delivery measurements during 1 week of product use | volume of filled applicators | Participants |
|
|
|
| Secondary | 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. | Per protocol all participants were included in the analysis. | Posted | Number | % of target dose filled into applicator | 3 dose delivery measurements during 1 week of product use | volume of filled applicator | Participants |
|
|
|
| Secondary | 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. | Per protocol, all participants were included in the analysis. | Posted | Mean | Standard Deviation | ml | 3 dose delivery measurements during 1 week of product use | dosing volume | Participants |
|
|
|
| Secondary | 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) | Per protocol all participants were included in the analysis. | Posted | Number | doses | 3 dose delivery measurements during 1 week of product use | dosing volume | Participants |
|
|
|
| Secondary | 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) | Per protocol all participants were included in the analysis. | Posted | Number | doses | 3 dose delivery measurements during 1 week of product use | dosing volume | Participants |
|
|
|
| Secondary | 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. | Per protocol all participants were included in the analysis. | Posted | Number | percent of target dose delivered | 3 dose delivery measurements during 1 week of product use | dosing volume | Participants |
|
|
|
| Secondary | 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. | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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.) | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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. | All participants were included in the analysis. Each participant could identify multiple reasons. As a result, the number of units analyzed is greater than the number of participants. | Posted | Number | participants | Final study visit (after completing both study arms) | responses | Participants |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | responses | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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. | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Primary | 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 | The number of participants for analysis was determined by counting the number of participants with colposcopic findings and baseline and after one week of product use. | Posted | Number | colposcopic findings | 7 days | colposcopic findings | Participants |
|
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| Secondary | 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". | All participants were included in the analysis. | Posted | Number | participants | Final study visit (after completing both study arms) |
|
|
|
| 0 |
| 25 |
| 10 |
| 25 |
| EG001 | Prefilled Applicator | plastic applicator (prefilled with Tenofovir 1% gel) | 0 | 25 | 6 | 25 |
| Common cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tooth pain | Gastrointestinal disorders | Non-systematic Assessment |
|
Investigators have agreed to provide drug sponsor with a copy of any draft manuscript or abstract for its review and comment at least thirty days prior to submission for publication and provide a copy of any draft presentation at least seven days in advance of any scientific meeting or conference.
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Difficult |
|
| Difficult |
|
| Title | Measurements |
|---|---|
|
| Ease of dispensing gel |
|
| Ease of disposal |
|
| Ease of storage |
|
| Overall comfort |
|
| Overall applicator preference |
|
| Uncomfortable |
|
| Title | Measurements |
|---|
|
| Peeling cervic or vagina |
|
| Petechiae (iatrogenic) |
|
| Ecchymosis left lateral vaginal wall (iatrogenic) |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|