A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring

• ClinicalTrials.gov Identifier: NCT01755754
• Recruitment Status: Completed
• First Posted: December 24, 2012
• Last Update Posted: September 28, 2017
• Sponsor: International Partnership for Microbicides, Inc.
• Information provided by (Responsible Party): International Partnership for Microbicides, Inc.

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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 Female Condoms With a Silicone Elastomer Vaginal Ring
• Study Start Date: August 2013
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Silicone Elastomer Vaginal Ring; Silicone Elastomer Vaginal Ring	Combination Product: Silicone Elastomer Vaginal Ring; Silicone Elastomer Vaginal Ring
Experimental: Female Condom; This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring	Combination Product: Silicone Elastomer Vaginal Ring; Silicone Elastomer Vaginal Ring; Device: Female Condom; Female condom

Outcome Measures

Primary Outcome Measures :

1. Total clinical failure rate [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 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 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;
7. Agree to not use genital jewelry or 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 or hypersensitive to vaginal lubricants such as Astorlige ®
4. Either partner not willing to refrain from wearing genital piercing jewelry for the duration of the study
5. History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
6. Consistently using male or female condoms for protection against sexually transmitted infection;
7. 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);
8. 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;
9. Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.)
10. Current participation in a study or other research involving a drug, device or other product;
11. 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

Los Angeles, California, United States, 90010

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

More Information

• Responsible Party: International Partnership for Microbicides, Inc.
• ClinicalTrials.gov Identifier: NCT01755754
• Other Study ID Numbers: IPM 033
• First Posted: December 24, 2012
• Last Update Posted: September 28, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes

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