Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

NCT01755741 | Completed Phase 1 FDA Drug

• 1 other identifier: IPM 029
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (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.

  4 weeks

Study Arms (2)

Placebo Vaginal Ring

EXPERIMENTAL

Placebo vaginal ring with condom use

Combination Product: Placebo Vaginal Ring; Device: Condom

Condom

OTHER

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

Device: Condom

Interventions

Placebo Vaginal Ring 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.

Placebo Vaginal Ring

Condom DEVICE

Male condom

Condom; Placebo Vaginal Ring

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (2)

California Family Health Council

Berkeley, California, 94710, United States

Location

California Family Health Council

Los Angeles, California, 90010, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Condoms

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Male; Contraceptive Devices; Equipment and Supplies

Study Officials

• Ron Frezieres

  California Family Health Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 24, 2012
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)