Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

• ClinicalTrials.gov Identifier: NCT01755741
• Recruitment Status: Completed
• First Posted: December 24, 2012
• Last Update Posted: March 29, 2018
• Sponsor: International Partnership for Microbicides, Inc.
• Information provided by (Responsible Party): International Partnership for Microbicides, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus	Combination Product: Placebo Vaginal Ring; Device: Condom	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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)
• Primary Purpose: Other
• 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 Start Date: February 2013
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Placebo Vaginal Ring; Placebo vaginal ring with condom use	Combination Product: Placebo Vaginal Ring; 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.; Device: Condom; Male condom
Condom; Male condoms during vaginal intercourse in presence and absence of the vaginal ring.	Device: Condom; Male condom

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent;
2. Age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit;
3. Healthy on the basis of medical history;
4. 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;
5. 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;
6. 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;
7. Agree to not use other vaginal products, except menstrual absorption products (e.g. tampons) and study lubricant during the trial;
8. Available for all visits and consent to follow all procedures scheduled for the trial;
9. At low risk for HIV infection.

Exclusion Criteria:

1. Males with untreated erectile dysfunction;
2. Female with positive pregnancy test;
3. Either partner allergic to natural latex or vaginal lubricants such as Astroglide ®;
4. History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
5. Currently using condoms for protection against sexually transmitted infection;
6. 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);
7. 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;
8. Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.);
9. Current participation in a study or other research involving a drug, device or other product;
10. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.

Contacts and Locations

Locations

United States, California

California Family Health Council

Berkeley, California, United States, 94710

California Family Health Council

Los Angeles, California, United States, 90010

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

• Principal Investigator: Ron Frezieres; California Family Health Council

More Information

• Responsible Party: International Partnership for Microbicides, Inc.
• ClinicalTrials.gov Identifier: NCT01755741
• Other Study ID Numbers: IPM 029
• First Posted: December 24, 2012
• Last Update Posted: March 29, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases