Comparative Safety Study of Two Vaginal Applicators With Tenofovir

NCT01283555 | Completed Results

• 1 other identifier: PATH HS-522
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the effect of two vaginal applicators, delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily use. The secondary objectives are to:

1. 1.Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir.
2. 2.Compare the acceptability of the user-filled applicator with the pre-filled applicator.

Conditions

Microbicide Applicator

Keywords

Microbicide, Applicator, Safety

Outcome Measures

Primary Outcomes (1)

• Number of Colposcopic Findings (Baseline and After One Week of Product Use)

  Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator

  7 days

Secondary Outcomes (22)

• Filled Volume

  3 dose delivery measurements during 1 week of product use

• Filling Precision (5% Range)

  3 dose delivery measurements during 1 week of product use

• Filling Precision (10% Range)

  3 dose delivery measurements during 1 week of product use

• Filling Accuracy (% of Target Dose)

  3 dose delivery measurements during 1 week of product use

• Dosing Volume (Expressed Volume)

  3 dose delivery measurements during 1 week of product use

Study Arms (2)

User-Filled Applicator

EXPERIMENTAL

Drug: Tenofovir

Prefilled applicator

OTHER

Drug: Tenofovir

Interventions

Tenofovir DRUG

Delivered using prefilled and user-filled applicator

Also known as: TFV

Prefilled applicator; User-Filled Applicator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Age 18 to 50, inclusive
• Pre-menopausal
• In good health as reported by individual
• Have regular menstrual cycles (24 to 35 days)
• Low risk for sexually transmitted infections (only one sexual partner in the last three months)
• Not pregnant or at risk of pregnancy (must either have had a tubal ligation, or currently be using a hormonal method of contraception)
• Negative on a urine pregnancy test
• Willing to abstain from sexual intercourse and masturbation during two 7-day periods when applicators are being used
• Willing to abstain from use of vaginal products during course of study (including douching, use of vaginal applicators for medication, lubrication, sex toys, other)
• Willing to follow procedural requirements of study
• Willing and able to provide informed consent for study participation
• Willing to provide investigator with phone number or address where she can be reached during the study

You may not qualify if:

• History of hysterectomy
• Pregnancy or within two months of last pregnancy outcome (delivery, spontaneous or induced abortion, medical or surgical management of ectopic pregnancy)
• Post-menopausal
• Breastfeeding
• Use of an intra-uterine device (IUD), cervical caps or diaphragm for contraceptive purposes
• Diagnosis or treatment for a sexually transmitted disease within the past 30 days;
• More than one sexual partner in the last 3 months
• Has had surgery on the external genitalia, vagina, or cervix within the past 3 months;
• Current or past use of any anti-retroviral therapies including but not limited to systemic Tenofovir (Viread®)
• Current or anticipated use of drugs on a daily basis that may reduce renal function (e.g. acyclovir or ibuprofen) or liver function (e.g. Tylenol)
• HIV positive at time of screening
• Hepatitis B surface antigen (HBsAg) positive at time of screening
• Positive test results for Neisseria gonorrhea, Chlamydia trachomatis, or Trichomonas vaginalis at time of screening.
• At baseline colposcopic exam (Visit 2), findings involving disruption of epithelium with disruption of blood vessels or deep disruption of epithelium alone. Any area of epithelium with bleeding will be considered deeply disrupted.
• Any abnormal finding on colposcopic exams which in the opinion of the investigator, precludes participation in the study

Sponsors & Collaborators

• PATH: lead
• CONRAD: collaborator
• Profamilia, Santo Domingo, DR: collaborator

Study Sites (1)

Clinica Profamilia

Santo Domingo, 10401, Dominican Republic

Location

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to an error in the interpretation of the user instructions and resulting depth of plunger insertion into the barrel by the participants, the dose delivery data for the prefilled applicator were not valid.

Results Point of Contact

• Title: Jessica Cohen
• Organization: PATH

jcohen@path.org

206-285-3500

Study Officials

• Vivian Brache

  Profamilia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 16, 2012
• Results First Posted: June 22, 2012

Record last verified: 2012-06

Locations

DO (1)