Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo Vaginal Ring
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 condoms provided by trial personnel during the time of participation. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
- Agree to not use 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 to natural latex or vaginal lubricants such as Astroglide ®;
- History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
- Currently using 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
- California Family Health Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Placebo Vaginal Ring
Condom
Arm Description
Placebo vaginal ring with condom use
Male condoms during vaginal intercourse in presence and absence of the vaginal ring.
Outcomes
Primary Outcome Measures
Total clinical failure rate (N slipped or broken/N total) off the penis or broke during intercourse or withdrawal, divided by the number of condoms used during intercourse.
Secondary Outcome Measures
Full Information
NCT ID
NCT01755741
First Posted
November 27, 2012
Last Updated
March 27, 2018
Sponsor
International Partnership for Microbicides, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01755741
Brief Title
Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng
Official Title
A Multicenter, Open-Label, Randomized, Two-Period, Crossover Non-inferiority Trial to Assess the Functionality of Male Condoms With a Silicone Elastomer Vaginal Ring
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (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
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the 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
Model Description
IPM 029 is an open-label, randomized, two-period, crossover non-inferiority trial conducted at two research centers in the U.S. to assess condom functionality during vaginal intercourse in healthy, monogamous heterosexual, sexually active couples.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Vaginal Ring
Arm Type
Experimental
Arm Description
Placebo vaginal ring with condom use
Arm Title
Condom
Arm Type
Other
Arm Description
Male condoms during vaginal intercourse in presence and absence of the vaginal ring.
Intervention Type
Combination Product
Intervention Name(s)
Placebo Vaginal Ring
Intervention Description
a silicone elastomer placebo vaginal ring, similar in composition to the dapivirine Ring-004 (which is currently used in IPM's ongoing Phase III program), except that it did not contain any active pharmaceutical agent, and a commercially available standard male latex condom with a silicone-based lubricant.
Intervention Type
Device
Intervention Name(s)
Condom
Intervention Description
Male condom
Primary Outcome Measure Information:
Title
Total clinical failure rate (N slipped or broken/N total) off the penis or broke during intercourse or withdrawal, divided by the number of condoms used during intercourse.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 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 condoms provided by trial personnel during the time of participation. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
Agree to not use 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 to natural latex or vaginal lubricants such as Astroglide ®;
History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
Currently using 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Frezieres
Organizational Affiliation
California Family Health Council
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Family Health Council
City
Berkeley
State/Province
California
ZIP/Postal Code
94710
Country
United States
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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Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng
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