HealthyPhase 2BZKNCT00692952
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
A Phase 2 study testing a novel Benzalkonium Chloride (BZK) contraceptive gel and LELEMI® contraceptive gel containing 50mg nonoxynol-9 in people with Healthy, run by Shanghai Institute of Planned Parenthood Research at 3 sites in China.
Trial summary
A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel, the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a currently marketed (in China)contraceptive… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- a novel Benzalkonium Chloride (BZK) contraceptive gel and LELEMI® contraceptive gel containing 50mg nonoxynol-9
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2004to Nov 2005
- Phase
- Phase 2
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at risk for pregnancy and desiring contraception
- having regular menstrual cycle (21-35 days)
- at low risk for HIV or other sexually transmitted infection
- sexually active
- use the test products as their primary method of contraception
- keep a diary of coital activity, product use, and adverse events
Who cannot join
- diagnosis of any vaginal infection or any symptom of STDs at baseline
- known allergy or hypersensitivity to N-9 or BZK
- menopause for more than one month
- breastfeeding
- vaginal bleeding with unknown reasons
- genitourinary system anomaly
Show all 9Show fewer
- hysteroptosis II or severe cystocele
- moderate to severe erosion of cervix
- malignant reproductive system tumors
Trial locations and contacts
3 sites in 1 country.
China3 sites
Gynecology and Obstetrics Hospital of Fudan University
Shanghai
International Peace Maternity and Child Care Center
Shanghai
Shanghai No. 1 Maternity and Child Care Center
Shanghai
About this study
A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel, the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).
Read the detailed description
A phase II, multicentric,randomized, controlled clinical trial.
- Conditions
- Healthy
- Being tested
- a novel Benzalkonium Chloride (BZK) contraceptive gel, LELEMI® contraceptive gel containing 50mg nonoxynol-9
- Keywords
- contraceptive efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a novel Benzalkonium Chloride (BZK) contraceptive gelDrug
insert 1 piece of the gel (containing 18mg BZK) into vagina before every coital act.
LELEMI® contraceptive gel containing 50mg nonoxynol-9Drug
insert 1 piece ofLELEMI® contraceptive gel within half an hour before every coital act
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 120 subjects using BenZalkonium Chloride Contraceptive Gel Receives: Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel |
| 2 | Active comparator | 120 subjects using Nonoxynol-9 contraceptive gel Receives: Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
contraceptive efficacy
Measured: March 2004 - November 2005
Secondary outcomes (1)
acceptability
Measured: March 2004 - November 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startMar 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Planned Parenthood Research
- Sponsor type
- Other government
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning, Fudan University, International Peace Maternity and Child Health Hospital, Shanghai No. 1 Maternity and Child Care Center, Chang Jiang Bio-pharmaceutical Co., Ltd.
- Investigators
- Jinxun XU, MD, Principal investigator, Shanghai Municipal Commission of Health and Family Planning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692952
- Sponsor's protocol ID
- China FDA 2003L02778
- Other IDs
- ISRCTN16203579
- Acronym
- BZK
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00692952
- Acronym / sponsor ID
- BZK / China FDA 2003L02778
- Conditions
- Healthy
- Keywords
- contraceptive efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Shanghai Institute of Planned Parenthood ResearchOther government
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning, Fudan University, International Peace Maternity and Child Health Hospital, Shanghai No. 1 Maternity and Child Care Center, Chang Jiang Bio-pharmaceutical Co., Ltd.
- Study start
- Mar 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 6 Jun 2008 (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.
A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel, the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).
Detailed description
A phase II, multicentric,randomized, controlled clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel120 subjects using BenZalkonium Chloride Contraceptive Gel |
| 2 | Active comparator | Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9120 subjects using Nonoxynol-9 contraceptive gel |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- at risk for pregnancy and desiring contraception
- having regular menstrual cycle (21-35 days)
- at low risk for HIV or other sexually transmitted infection
- sexually active
- use the test products as their primary method of contraception
Key exclusion criteria (9 listed)
- diagnosis of any vaginal infection or any symptom of STDs at baseline
- known allergy or hypersensitivity to N-9 or BZK
- menopause for more than one month
- breastfeeding
- vaginal bleeding with unknown reasons
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 |
|---|---|---|
| a novel Benzalkonium Chloride (BZK) contraceptive gelinsert 1 piece of the gel (containing 18mg BZK) into vagina before every coital act. | Drug | 1 |
| LELEMI® contraceptive gel containing 50mg nonoxynol-9insert 1 piece ofLELEMI® contraceptive gel within half an hour before every coital act | Drug | 2 |
Primary outcome
contraceptive efficacy
Time frame: March 2004 - November 2005
1 secondary outcome
acceptability
Time frame: March 2004 - November 2005
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 10 Jul 2009.
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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.
Jinxun XU, MD principal investigator
Shanghai Municipal Commission of Health and Family Planning
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing a novel Benzalkonium Chloride (BZK) contraceptive gel and LELEMI® contraceptive gel containing 50mg nonoxynol-9 in people with Healthy, run by Shanghai Institute of Planned Parenthood Research at 3 sites in China.
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 6 inclusion and 9 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 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 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.
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 (time frame: March 2004 - November 2005). 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 10 Jul 2009.