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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755754
First Posted: December 24, 2012
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
  Purpose
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.

Condition Intervention Phase
Human Immunodeficiency Virus Combination Product: Silicone Elastomer Vaginal Ring Device: Female Condom Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • Total clinical failure rate [ Time Frame: 8 weeks ]

Enrollment: 160
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silicone Elastomer Vaginal Ring
Silicone Elastomer Vaginal Ring
Combination Product: Silicone Elastomer Vaginal Ring
Silicone Elastomer Vaginal Ring
Experimental: Female Condom
This trial will test the performance of female condoms when used concurrently with a placebo vaginal ring
Combination Product: Silicone Elastomer Vaginal Ring
Silicone Elastomer Vaginal Ring
Device: Female Condom
Female condom

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755754


Locations
United States, California
California Family Health Council
Los Angeles, California, United States, 90010
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
  More Information

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01755754     History of Changes
Other Study ID Numbers: IPM 033
First Submitted: December 14, 2012
First Posted: December 24, 2012
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases