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PregnancyPhase 2/3NCT00065858

Effectiveness of BufferGel as a Vaginal Contraceptive

A Phase 2/3 study testing BufferGel in people with Pregnancy, run by Premier Research at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
BufferGel
How many people
975 participants
Where
9 sitesUnited States
Study dates
Sep 2001to Apr 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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
  • Participant's Sexual Partner Must Not Be/Have
  • Infertile
  • Treated for Chlamydia trachomatis or Neisseria gonorrhoeae in the 6 months prior to study entry
  • HIV infected
  • More than one sexual partner in the 4 months prior to study entry
  • Engaged in homosexual intercourse
  • Shared injection drug needles in the 6 months prior to study entry
  • Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex

Who cannot join

  • 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
Show all 27Show fewer
  • 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
  • Lower abdominal or pelvic pain in the month prior to study entry
  • Abnormal finding on pelvic examination which, in the view of the study investigator, precludes participation in study
  • Vaginal or cervical irritation, including vaginal or cervical epithelial disruption, ulceration, bleeding, petechiae, sloughing, or areas of obvious erythema
  • Vaginal or cervical biopsy or surgery in the 3 months prior to study entry
  • Vaginal or systemic antibiotics, antivirals, or antifungals in the 14 days prior to study entry
  • Depo-Provera injection in the 10 months prior to study
  • Vaginal or cervical abnormality that would interfere with the proper placement and retention of test product and diaphragm
  • Abnormal Pap smear in the 12 months prior to study entry
  • Consume (on average) greater than 2 to 3 alcoholic beverages per day
  • Drug abuse (recreational, prescription, or OTC) in the 12 months prior to study entry
  • Investigational drug or device use in the month prior to study entry
  • Previously participated in or completed this study

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • California Family Health Council

    Berkeley, California

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University of Colorado

    Denver, Colorado, 80045

  • California Family Health Council

    Los Angeles, California

  • New York University

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Randomized, Controlled Trial of the Efficacy, Safety, and Acceptability of BufferGel

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.

Read the detailed description

Vaginal acidity is thought to be one means by which the vagina prevents overgrowth or colonization by harmful microbial flora. Sperm and many STD pathogens, including HSV-1 and HSV-2, Neisseria gonorrhoeae, Treponema pallidum, Haemophilus ducreyi, and a variety of bacterial vaginosis-associated bacteria, are inactivated at pH less than 5 in vitro. BufferGel, a vaginal spermicide and microbicide, is an acidic buffer that maintains the vagina at or near its natural state of mild acidity. Formulated at vaginal pH (pH 3.9), BufferGel prevents or limits the semen-induced rise in vaginal pH. Carbopol 974P, the buffering agent in BufferGel, is a high molecular weight, cross-linked, polyacrylic acid used as a gelling or tableting agent in many pharmaceuticals; it has a well-documented record of mucosal safety in animals and humans. This study will determine the safety and contraceptive efficacy of BufferGel spermicide used with a diaphragm compared to Gynol II spermicide used with a diaphragm. The study will also measure the frequency of bacterial vaginosis, urinary tract infections, and cervical lesions in women using BufferGel compared with Gynol II.

Participants in this study will be fitted for a diaphragm and randomized to receive either BufferGel or Gynol II. All participants will be instructed on the use of the test product with the diaphragm. Participants will be followed through 6 menstrual cycles (approximately 7 months) and will have 4 study visits and one study phone call. Some participants may enroll in an extended version of the study and be followed for an additional 6 cycles and 2 additional study visits. Study visits will include a gynecologic exam, Pap smear, and blood and urine tests. Participants will be asked to keep a diary to record information on product use. Some participants may also be asked to enroll in a colposcopy substudy. These participants will undergo colposcopy at study entry and after cycles 1, 3 and 6.

Conditions
Pregnancy
Being tested
BufferGel
Keywords
Contraception, Nonoxynol 9, Microbicide, Spermicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BufferGelDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2003 (estimated)
  2. Study startSep 2001
  3. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
975 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00065858
Sponsor's protocol ID
CCN003
Status last verified
Aug 2016
First submitted
1 Aug 2003
Last updated
19 Aug 2016
Results posted
No

Publications

  • 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.

    PubMed 17766603

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BufferGel in people with Pregnancy, run by Premier Research at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00065858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.

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