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Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

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ClinicalTrials.gov Identifier: NCT01755741
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Combination Product: Placebo Vaginal Ring Device: Condom Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: IPM 029 is an open-label, randomized, two-period, crossover non-inferiority trial conducted at two research centers in the U.S. to assess condom functionality during vaginal intercourse in healthy, monogamous heterosexual, sexually active couples.
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 Male Condoms With a Silicone Elastomer Vaginal Ring
Study Start Date : February 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Placebo Vaginal Ring
Placebo vaginal ring with condom use
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

Condom
Male condoms during vaginal intercourse in presence and absence of the vaginal ring.
Device: Condom
Male condom




Primary Outcome Measures :
  1. 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. [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 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 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.

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): NCT01755741


Locations
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United States, California
California Family Health Council
Berkeley, California, United States, 94710
California Family Health Council
Los Angeles, California, United States, 90010
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
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Principal Investigator: Ron Frezieres California Family Health Council

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Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01755741     History of Changes
Other Study ID Numbers: IPM 029
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases