Overview

Functionality of Male Condomes With a Silicone Elastomer Vaginal RIng

Status:
Completed
Trial end date:
0000-00-00
Target enrollment:
70
Participant gender:
Both
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
International Partnership for Microbicides, Inc.
Last Updated:
2016-12-14
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.