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

Human Immunodeficiency Virus Clinical Trial

Official title:

A Multicenter, Open-label, Randomized, Two-period, Crossover Non-inferiority Trial to Assess the Functionality of Female Condoms With a Silicone Elastomer Vaginal Ring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755754
• Other study ID #: IPM 033
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2012
• Last updated: September 26, 2017
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2017
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Combination Product:
• Silicone Elastomer Vaginal Ring
Silicone Elastomer Vaginal Ring

Device:
• Female Condom
Female condom

Locations

Country	Name	City	State
United States	California Family Health Council	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total clinical failure rate		8 weeks