Functionality of Male Condoms 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 Male Condoms With a Silicone Elastomer Vaginal Ring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755741
• Other study ID #: IPM 029
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2012
• Last updated: March 27, 2018
• Start date: February 2013
• Est. completion date: October 2013

Study information

• Verified date: March 2018
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 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 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.

Related Conditions & MeSH terms

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

Intervention

Combination Product:
• Placebo Vaginal Ring
a silicone elastomer placebo vaginal ring, similar in composition to the dapivirine Ring-004 (which is currently used in IPM's ongoing Phase III program), except that it did not contain any active pharmaceutical agent, and a commercially available standard male latex condom with a silicone-based lubricant.

Device:
• Condom
Male condom

Locations

Country	Name	City	State
United States	California Family Health Council	Berkeley	California
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 (N slipped or broken/N total) off the penis or broke during intercourse or withdrawal, divided by the number of condoms used during intercourse.		4 weeks