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

NCT ID: NCT01755754

Last Updated: 2017-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-03-31

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.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Silicone Elastomer Vaginal Ring

Silicone Elastomer Vaginal Ring

Group Type: EXPERIMENTAL

Silicone Elastomer Vaginal Ring

Intervention Type: COMBINATION_PRODUCT

Silicone Elastomer Vaginal Ring

Female Condom

This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring

Group Type: EXPERIMENTAL

Silicone Elastomer Vaginal Ring

Intervention Type: COMBINATION_PRODUCT

Silicone Elastomer Vaginal Ring

Female Condom

Intervention Type: DEVICE

Female condom

Interventions

Silicone Elastomer Vaginal Ring

Silicone Elastomer Vaginal Ring

Intervention Type: COMBINATION_PRODUCT

Female Condom

Female condom

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

California Family Health Council

Los Angeles, California, United States

Countries

United States

Other Identifiers

IPM 033

Identifier Type: -

Identifier Source: org_study_id