A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Silicone Elastomer Vaginal Ring
Female Condom
Sponsored by
About this trial
This is an interventional other trial for Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- Mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent;
- Age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit;
- Healthy on the basis of medical history;
- Not at risk of pregnancy, i.e., female is surgically sterile, using an IUD, or using effective hormonal contraception, or has a vasectomized partner. The use of vaginal contraceptive rings will not be allowed;
- Sexually active and agree to have at least 8 acts of penile-vaginal intercourse using a study condom over 2 periods of up to 4 weeks each;
- Agree to use only the female condoms provided by trial personnel during the time of participation and not to use male condoms during the trial. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
- Agree to not use genital jewelry or other vaginal products, except menstrual absorption products (e.g., tampons) and study lubricant during the trial;
- Available for all visits and consent to follow all procedures scheduled for the trial;
- At low risk for HIV infection.
Exclusion Criteria:
- Males with untreated erectile dysfunction;
- Female with positive pregnancy test;
- Either partner allergic or hypersensitive to vaginal lubricants such as Astorlige ®
- Either partner not willing to refrain from wearing genital piercing jewelry for the duration of the study
- History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
- Consistently using male or female condoms for protection against sexually transmitted infection;
- Either partner taking any topical or oral medication to treat a urogenital condition at enrollment, except medication for the male partner to treat erectile dysfunction (e.g., tadalafil, sildenafil);
- Either partner with a self-reported or clinically diagnosed urogenital condition (e.g. itching, burning, irritation, etc.) that, in the opinion of the Investigator, could affect use of the study condoms or ability to interpret trial data;
- Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.)
- Current participation in a study or other research involving a drug, device or other product;
- Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
Sites / Locations
- California Family Health Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Silicone Elastomer Vaginal Ring
Female Condom
Arm Description
Silicone Elastomer Vaginal Ring
This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring
Outcomes
Primary Outcome Measures
Total clinical failure rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01755754
First Posted
December 14, 2012
Last Updated
September 26, 2017
Sponsor
International Partnership for Microbicides, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01755754
Brief Title
A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring
Official Title
A Multicenter, Open-label, Randomized, Two-period, Crossover Non-inferiority Trial to Assess the Functionality of Female Condoms With a Silicone Elastomer Vaginal Ring
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Partnership for Microbicides, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess the functionality of female condoms with a silicone elastomer vaginal ring.
Detailed Description
This was an open-label, randomized, 2-period, crossover non-inferiority trial, conducted over 4.5 months at two research centers in the USA among 81 healthy, monogamous, heterosexual, sexually active couples to assess the functionality of female lubricated, nitrile condoms during vaginal intercourse in the presence and absence of a silicone elastomer placebo vaginal ring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silicone Elastomer Vaginal Ring
Arm Type
Experimental
Arm Description
Silicone Elastomer Vaginal Ring
Arm Title
Female Condom
Arm Type
Experimental
Arm Description
This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring
Intervention Type
Combination Product
Intervention Name(s)
Silicone Elastomer Vaginal Ring
Intervention Description
Silicone Elastomer Vaginal Ring
Intervention Type
Device
Intervention Name(s)
Female Condom
Intervention Description
Female condom
Primary Outcome Measure Information:
Title
Total clinical failure rate
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent;
Age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit;
Healthy on the basis of medical history;
Not at risk of pregnancy, i.e., female is surgically sterile, using an IUD, or using effective hormonal contraception, or has a vasectomized partner. The use of vaginal contraceptive rings will not be allowed;
Sexually active and agree to have at least 8 acts of penile-vaginal intercourse using a study condom over 2 periods of up to 4 weeks each;
Agree to use only the female condoms provided by trial personnel during the time of participation and not to use male condoms during the trial. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
Agree to not use genital jewelry or other vaginal products, except menstrual absorption products (e.g., tampons) and study lubricant during the trial;
Available for all visits and consent to follow all procedures scheduled for the trial;
At low risk for HIV infection.
Exclusion Criteria:
Males with untreated erectile dysfunction;
Female with positive pregnancy test;
Either partner allergic or hypersensitive to vaginal lubricants such as Astorlige ®
Either partner not willing to refrain from wearing genital piercing jewelry for the duration of the study
History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
Consistently using male or female condoms for protection against sexually transmitted infection;
Either partner taking any topical or oral medication to treat a urogenital condition at enrollment, except medication for the male partner to treat erectile dysfunction (e.g., tadalafil, sildenafil);
Either partner with a self-reported or clinically diagnosed urogenital condition (e.g. itching, burning, irritation, etc.) that, in the opinion of the Investigator, could affect use of the study condoms or ability to interpret trial data;
Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.)
Current participation in a study or other research involving a drug, device or other product;
Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
Facility Information:
Facility Name
California Family Health Council
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring
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