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Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms

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ClinicalTrials.gov Identifier: NCT02569697
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
CONRAD

Brief Summary:
The purpose of this study is to develop markers for use of placebo vaginal products and measure markers of mucosal semen exposure among healthy women. The study will also monitor safety of placebo product use.

Condition or disease Intervention/treatment Phase
HIV Other: HEC Placebo gel Other: Placebo Intravaginal Ring Other: Placebo Vaginal Film Other: Placebo Vaginal Insert Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms
Study Start Date : October 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
HEC Placebo Gel
The placebo gel will come in pre-filled individual applicators (4mL). Placebo gel is clear in color and contains HEC as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide.
Other: HEC Placebo gel
Placebo Vaginal Insert
The placebo vaginal inserts will be supplied in white plastic bottles. The placebo inserts are white to off-white in color, uncoated and bullet-shaped. The inserts are composed of ingredients generally recognized as safe including isomalt, xylitol, polyvinylpyrrolidone K 30, hydroxypropyl methylcellulose, poloxamer, and sodium stearyl fumarate. The inserts are approximately ½ to 1 inch long and approximately ¼ to ½ inch thick, similar in size to vaginal tablets that are currently available.
Other: Placebo Vaginal Insert
Placebo Vaginal Film
The placebo vaginal films will be individually wrapped. The placebo vaginal film is a thin, clear to translucent sheet with dimensions of 2 in x 2 in. The ingredients include hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC, E5), sodium carboxymethyl cellulose (NaCMC), and glycerin.
Other: Placebo Vaginal Film
Placebo Intravaginal ring (IVR)
The placebo IVRs will be supplied in individual foil pouches. Each ring has a longer white to off-white segment and a shorter transparent/translucent segment, and ingredients include polyurethane, glycerin, water and modified starch.
Other: Placebo Intravaginal Ring



Primary Outcome Measures :
  1. Presence or absence of spectroscopic pattern signatures or other analytical methods measures of excipient or placebo products or vaginal bacteria in vaginal swabs [ Time Frame: 1 - 7 days ]
  2. Presence or absence of penetration of vaginally-derived biologic analytes or biofilms detected on returned IVRs [ Time Frame: 1 - 7 days ]
  3. Presence or absence of DNA (deoxyribonucleic acid) sequences of SRY (Sex-determining region in the Y chromosome) and TSPY4 (testis-specific protein Y-encoded) [ Time Frame: 1 - 7 days ]
  4. Presence or absence of amelogenin [ Time Frame: 1 - 7 days ]
  5. Changes in dimensions, weight, biologic or chemical composition of IVR [ Time Frame: 1 day, 1 week, 1 month ]
    Assessments in dimensions, weight, biologic or chemical composition will be aggregated to inform changes in overall IVR characteristics


Secondary Outcome Measures :
  1. Treatment-emergent adverse experiences among female participants per participant report: urogenital, product related, and/or serious [ Time Frame: baseline and at 1 day, 1 week and 1 month ]
  2. Changes on pelvic exam, as observed by the naked eye [ Time Frame: baseline and at 1 day, 1 week and 1 month ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Volunteers must meet all of the following criteria prior to genital sampling at Visit 2:

  • Age 18 to 50 years, inclusive
  • General good health (by volunteer history and per investigator judgment) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes)
  • History of Pap smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at V1
  • Willing to give voluntary consent and sign an informed consent form
  • Willing and able to comply with protocol requirements
  • Protected from pregnancy by:

    • hysterectomy
    • reliable methods of contraception other than male or female condoms, contraceptive IVR or male partner's vasectomy
    • abstinence (IVR group only)
    • or in a same sex relationship (IVR group only)
  • For gel, insert or film assigned participants: Willing to engage in intercourse with a male sexual partner without the use of male or female condoms as required in the protocol
  • For gel, insert or film assigned participants: In a mutually monogamous relationship with a male partner who:

    • Is at least 18 years old
    • Is not known to be HIV positive
    • Has no known risk for STIs
    • Has not undergone a vasectomy
    • Is not known to have azoospermia
    • Is willing and able to comply with protocol requirements regarding sexual activity/ abstinence
    • Can engage with the participant in vaginal intercourse without condoms, as specified in the protocol 8.2. Exclusion Criteria

Volunteers must not meet any of the following criteria prior to genital sampling at Visit 2:

  • Currently pregnant
  • Currently breastfeeding or planning to breastfeed during the course of the study
  • History of sensitivity/allergy to any component of the vaginal products for either the volunteer or her sexual partner, as applicable
  • Use of vaginal douches, creams or gels, other than the study product, at any time during the study, beginning 7 days prior to V2
  • In the last six months, either the volunteer or her sexual partner (as applicable) diagnosed with or treated for any STI. Note: Women with a history of genital herpes who have been asymptomatic for at least six months may be considered for eligibility
  • Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis or HIV
  • Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)
  • Known current drug or alcohol abuse which could impact study compliance
  • Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
  • Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her sexual partner (as applicable) which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data

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): NCT02569697


Locations
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
CONRAD

Responsible Party: CONRAD
ClinicalTrials.gov Identifier: NCT02569697     History of Changes
Other Study ID Numbers: D15-135
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Anti-Infective Agents