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

NCT01755754 | Completed Phase 1 FDA Drug

• 1 other identifier: IPM 033
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Total clinical failure rate

  8 weeks

Study Arms (2)

Silicone Elastomer Vaginal Ring

EXPERIMENTAL

Silicone Elastomer Vaginal Ring

Combination Product: Silicone Elastomer Vaginal Ring

Female Condom

EXPERIMENTAL

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

Combination Product: Silicone Elastomer Vaginal Ring; Device: Female Condom

Interventions

Silicone Elastomer Vaginal Ring COMBINATION_PRODUCT

Silicone Elastomer Vaginal Ring

Female Condom; Silicone Elastomer Vaginal Ring

Female Condom DEVICE

Female condom

Female Condom

Eligibility Criteria

• Age: 18 Years - 45 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 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;
• Agree to not use genital jewelry or 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 or hypersensitive to vaginal lubricants such as Astorlige ®
• Either partner not willing to refrain from wearing genital piercing jewelry for the duration of the study
• History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
• Consistently using male or female 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 (1)

California Family Health Council

Los Angeles, California, 90010, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Single-Use Internal Condom

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, Female; Contraceptive Devices; Equipment and Supplies

Study Design

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

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 24, 2012
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)