ContraceptionPhase 2/3NCT00397670
Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm
A Phase 2/3 study testing Drug: BufferGel® with diaphragm in people with Contraception, run by ReProtect Inc.
Trial summary
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Drug: BufferGel® with diaphragm
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to May 2006
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- be healthy women, who are sexually active, at risk for pregnancy and desiring contraception
- be within the age range of 18 through 40 years inclusive
- be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection, currently have (≥4 months) a single sexual partner who is also at low-risk for HIV or STD infection and expect to have the same partner for the duration of the study
- have a negative urine pregnancy test at the admission visit
- have normal cyclic menses with a usual length of 24 to 35 days over the last 2 months
- have a documented history of at least one spontaneous, normal menstrual cycle (two menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy
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- be willing to accept a risk of pregnancy
- be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle for a period of approximately seven months
- be willing to be randomized to either study treatment as applicable
- be 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
- be willing to only use the test product with diaphragm as the primary method of contraception over the course of the study [with the exception of emergency contraception pills (ECPs), when indicated]
- be capable of using the product and diaphragm properly and agree to observe all study directions and requirements
Who cannot join
- have a history of allergy or sensitivity to spermicides, products containing N-9, and/or products containing latex
- have a history of toxic shock syndrome
- have had two or more UTIs in the past year or currently have a suspected or diagnosed UTI or vaginitis by dipstick urinalysis or wet mount, unless treated and proof of cure is documented
- be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study
- have a history of infertility or conditions which may lead to infertility
- have contraindications to pregnancy (medical condition) or chronic use of class D or X medications
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- have been hospitalized for pelvic inflammatory disease without a subsequent intrauterine pregnancy
- have had more than one sexual partner in the past 4 months
- have shared injection drug needles within the past 6 months
- have, or suspected to have, HIV infection
- have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within the 3 months prior to screening, or have clinical evidence of HSV on exam
- have been diagnosed with any other STDs (including trichomonas) in the 6 months prior to the screening visit
- be lactating or breastfeeding have had a Depo-Provera injection in the 10 months prior to screening
- have a vaginal or cervical abnormality that would interfere with the proper placement and retention of test product and diaphragm
- In addition, in order to be eligible to participate in the trial, potential subjects must state that, to her best knowledge, her sexual partner meets the following criteria:
- is not infertile
- has not been treated for Chlamydia trachomatis or N. gonorrhoeae in the past 6 months
- has not been previously diagnosed with, or suspected to have, HIV infection
- has not had more than one sexual partner in the past 4 months
- has not engaged in homosexual intercourse in the past 10 years
- has not shared injection drug needles in the past 10 years
- has no history of allergy or sensitivity to spermicides or products containing N-9
- has no history of allergy or sensitivity to products containing latex
About this study
Official title: A Multicenter Open-Label Study of the Safety and Contraceptive Efficacy of BufferGel® Spermicide Used With Diaphragm
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.
- Conditions
- Contraception
- Being tested
- Drug: BufferGel® with diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: BufferGel® with diaphragmDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive efficacy (pregnancy rate) at six months (183 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startJan 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- ReProtect Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Premier Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397670
- Sponsor's protocol ID
- CCN 003OL
- Status last verified
- Nov 2006
- First submitted
- 8 Nov 2006
- Last updated
- 9 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Study of the Safety and Contraceptive Efficacy of BufferGel® Spermicide Used With Diaphragm
- ClinicalTrials.gov ID
- NCT00397670
- Acronym / sponsor ID
- CCN 003OL
- Conditions
- Contraception
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- ReProtect IncIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Premier Research
- Study start
- Jan 2004
- Study completion
- May 2006
- First posted
- 9 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- be healthy women, who are sexually active, at risk for pregnancy and desiring contraception
- be within the age range of 18 through 40 years inclusive
- be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection, currently have (≥4 months) a single sexual partner who is also at low-risk for HIV or STD infection and expect to have the same partner for the duration of the study
- have a negative urine pregnancy test at the admission visit
- have normal cyclic menses with a usual length of 24 to 35 days over the last 2 months
Key exclusion criteria (23 listed)
- have a history of allergy or sensitivity to spermicides, products containing N-9, and/or products containing latex
- have a history of toxic shock syndrome
- have had two or more UTIs in the past year or currently have a suspected or diagnosed UTI or vaginitis by dipstick urinalysis or wet mount, unless treated and proof of cure is documented
- be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study
- have a history of infertility or conditions which may lead to infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: BufferGel® with diaphragm | Drug | – |
Primary outcome
Contraceptive efficacy (pregnancy rate) at six months (183 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Drug: BufferGel® with diaphragm in people with Contraception, run by ReProtect Inc.
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 12 inclusion and 23 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 9 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Contraceptive efficacy (pregnancy rate) at six months (183 days).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2006.