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

Completed · Phase 1

Conditions studied: Human Immunodeficiency Virus

In brief

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.

Key facts

Study ID

NCT01755754

Run by

International Partnership for Microbicides, Inc.

People needed

160

Starts

2013-08-01

Expected to finish

2014-03-01

Last updated by the study team

2017-09-28

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• California Family Health Council — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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