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

This was an open-label, randomized, 2-period, crossover non-inferiority trial, conducted over
4.5 months at two research centers in the USA among 81 healthy, monogamous, heterosexual,
sexually active couples to assess the functionality of female lubricated, nitrile condoms
during vaginal intercourse in the presence and absence of a silicone elastomer placebo
vaginal ring.

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 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;

7. Agree to not use genital jewelry or 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 or hypersensitive to vaginal lubricants such as Astorlige ®

4. Either partner not willing to refrain from wearing genital piercing jewelry for the
duration of the study

5. History by self-report of recurrent or a recently-treated (within past 2 weeks)
sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);

6. Consistently using male or female condoms for protection against sexually transmitted
infection;

7. 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);

8. 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;

9. Females, based on findings from a pelvic examination, who are not suitable candidates
for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.)

10. Current participation in a study or other research involving a drug, device or other
product;

11. Any condition(s) that, in the opinion of the Investigator, might interfere with
adherence to trial requirements or evaluation of the trial objectives.