Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

NCT ID: NCT01755741

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-10-31

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.

Conditions

Human Immunodeficiency Virus

Study Design

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

Study Groups

Placebo Vaginal Ring

Placebo vaginal ring with condom use

Group Type: EXPERIMENTAL

Placebo Vaginal Ring

Intervention Type: COMBINATION_PRODUCT

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.

Condom

Intervention Type: DEVICE

Male condom

Condom

Male condoms during vaginal intercourse in presence and absence of the vaginal ring.

Group Type: OTHER

Condom

Intervention Type: DEVICE

Male condom

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Condom

Male 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Frezieres

Role: PRINCIPAL_INVESTIGATOR

California Family Health Council

Locations

California Family Health Council

Berkeley, California, United States

California Family Health Council

Los Angeles, California, United States

Countries

United States

Other Identifiers

IPM 029

Identifier Type: -

Identifier Source: org_study_id