A double-blind, randomised, placebo-controlled, dose escalation trial to evaluate the safety
and to assess local and systemic pharmacokinetics of ds003 vaginal tablets administered to
healthy HIV-negative women.
Drug: DS003 vaginal tablet
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Locations near you
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Full eligibility criteria for NCT02877979
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Women who meet any of the
Currently pregnant or had their last pregnancy outcome within 3 months prior to screening
Currently or within 2 months of participation in any other clinical research trial involving investigational or marketed products prior to screening
Untreated symptomatic urogenital infections, e.g. urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, prior to enrolment
Have a Grade 2 or higher pelvic examination finding, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies
History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
Current vulvar or vaginal symptoms/abnormalities that could influence the trial results
Cervical cytology at screening that requires cryotherapy, biopsy, treatment, or further evaluation
Symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
Any Grade 2, 3 or 4 haematology, biochemistry or urinalysis laboratory abnormality at baseline (screening) according to the current version of the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
Any serious acute, chronic or progressive disease (e.g. any known history of neoplasm, cancer, diabetes, epilepsy, cardiac disease, autoimmune disease, HIV, AIDS, or blood dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition
Have undergone a hysterectomy
History of drug or substance abuse within 1 year of enrolment
Use of tobacco within 6 months of enrolment
Not willing to abstain from alcohol from 14 days prior to enrolment until completion of trial participation
Have had significant blood loss, or have donated or received one or more units of blood within 6 weeks prior to enrolment
Have a positive urine drug or positive breath alcohol screen at screening or enrolment
Any disease or condition (medical or surgical) that might compromise haematological, cardiovascular, pulmonary, renal, gastrointestinal, or central nervous system function; or any other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the investigational product, or that would place the participant at increased risk, as determined by the Investigator
Regular use of, or have received, any concomitant prescription, over-the-counter, or herbal medications or nutritional supplements within 14 days prior to enrolment
Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
All locations for NCT02877979
View full eligibility
Tris trial is registered with FDA with number: NCT02877979. The sponsor of the trial is International Partnership for Microbicides, Inc. and it is looking for 36 volunteers for the current phase.
Official trial title: A Double-blind, Randomised, Placebo-controlled, Dose Escalation Trial to Evaluate the Safety and to Assess Local and Systemic Pharmacokinetics of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women
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