NCT00065858

Brief Summary

BufferGel is a new contraceptive gel designed to be used with a diaphragm. In addition to preventing pregnancy, BufferGel may also prevent some types of sexually transmitted diseases (STDs). This study will compare BufferGel to Gynol II, a currently available contraceptive gel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
975

participants targeted

Target at P75+ for phase_2 pregnancy

Timeline
Completed

Started Sep 2001

Typical duration for phase_2 pregnancy

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

First QC Date

August 1, 2003

Last Update Submit

August 17, 2016

Conditions

Pregnancy

Keywords

ContraceptionNonoxynol 9MicrobicideSpermicide

Interventions

BufferGelDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • General good health
  • Sexually active, at risk for pregnancy, and desiring contraception
  • Low-risk for HIV or STD infection
  • Single sexual partner who is at low-risk for HIV or STD infection for 6 months prior to study entry
  • Expect to have same sexual partner for duration of the study
  • Normal cyclic menses with a usual length of 21 to 35 days
  • Documented history of at least two spontaneous, normal menstrual cycles since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy
  • Willing to accept a risk of pregnancy
  • Willing to engage in an average of 1 to 2 acts of heterosexual vaginal intercourse per week for a period of 6 months
  • Willing to be fitted with a diaphragm and use the diaphragm with test product during all acts of heterosexual vaginal intercourse for the duration of the study
  • Willing to only use the test product with diaphragm as the sole method of contraception over the course of the study (with the exception of emergency contraceptive pills when indicated)
  • Capable of using the product and diaphragm properly
  • Willing to keep a diary to record coital information, product use information, information about the use of other vaginal products, and sign and symptom data for self and partner
  • Agree not to participate in any other clinical trials during the course of the study
  • Written informed consent to participate in the trial
  • +8 more criteria

You may not qualify if:

  • Pregnant or desire to become pregnant during the course of the study
  • History of infertility or conditions that may lead to infertility
  • Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex
  • History of toxic shock syndrome (TSS)
  • Two or more urinary tract infections (UTIs) in the 12 months prior to study entry
  • Current suspected or diagnosed urinary tract infection or vaginitis
  • Contraindications to pregnancy (medical condition or chronic use of medications contraindicated for pregnancy)
  • Treated with antibiotics for pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy
  • More than one sexual partner in the 4 months prior to study entry
  • Shared injection drug needles in the 6 months prior to study entry
  • HIV infected or suspected HIV infection
  • Genital herpes simplex virus (HSV) infection with the first occurrence (initial episode) within 3 months prior to study entry or have clinical evidence of HSV on exam
  • Sexually transmitted diseases (STDs) in the 3 months prior to study entry
  • Lactating or breastfeeding
  • Abnormal vaginal bleeding or spotting in the month prior to study entry
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

California Family Health Council

Berkeley, California, United States

Location

California Family Health Council

Los Angeles, California, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

New York University

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • Barnhart KT, Rosenberg MJ, MacKay HT, Blithe DL, Higgins J, Walsh T, Wan L, Thomas M, Creinin MD, Westhoff C, Schlaff W, Archer DF, Ayers C, Kaunitz A, Das S, Moench TR. Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):577-86. doi: 10.1097/01.AOG.0000278078.45640.13.

    PMID: 17766603DERIVED

MeSH Terms

Interventions

BufferGel

Study Officials

  • H. Trent MacKay, MD, MPH

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

September 1, 2001

Study Completion

April 1, 2005

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(9)