ContraceptionNCT03833115
Spermicidal Efficacy Of A Vaginal Gel
A study testing vaginal gel containing or not sodium lauryl sulfate in people with Contraception, run by Laval University at 1 site in Canada.
Trial summary
There is an urgent need to develop non-hormonal innovative preventive measures under the control of women that can prevent unintended pregnancy. Based on our experimental data, the use of a gel formulation containing SLS could represent a potent and safe topical vaginal spermicide. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- vaginal gel containing or not sodium lauryl sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2018to 4 Dec 2020
- Phase
- Interventional
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman
- Healthy woman seeking to space or delay pregnancy aged between 18 and 49 years
- Sexually active
- Willing to give written informed consent to participate in the trial
- Normal physical and gynecological examination
- Negative urine pregnancy test at screening
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- Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside the vagina
- Female participant in first phase of the study must be already using and agreeing continuous use of a reliable method of contraception defined as use of hormonal contraception (pill, patch or injection, in accordance with the approved product label) during treatment with the study product and must agree to maintain the contraceptive method for at least 2 weeks after discontinuation of study product if not participating in second phase of the study. If the female participant participates in the second phase of the study, she must stop using the method of contraception during product application and use only the test product provided (vaginal gel-SLS).
- Man
- Healthy man aged 18 years and older
- Sexually active
- Normal spermogram at inclusion
- Normal physical examination
- Willing to give written informed consent to participate in the trial
- Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside the vagina for post coital test.
Who cannot join
- Woman
- Abnormal physical/gynecological examination
- Pregnant at enrolment
- Lactating or breastfeeding
- History of vaginitis during the last 3 months
- History of using vaginal medications during the last 3 months
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- History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, vulvo-vaginal or cervical HPV) during the last 12 months
- STIs at time of screening
- Abnormal laboratory findings with clinical significance
- Allergy to applicator material (polyethylene), to gel polymer (polyoxyethylene-polyoxypropylene)
- History of toxic shock syndrome (TSS)
- Use of other contraceptive methods during the study period other than the ones accepted in the study including intrauterine device (IUD), diaphragm, spermicide, contraceptive ring and fertility awareness methods (first phase of the study, no contraception during the second phase)
- Post-menopausal (12 months of spontaneous amenorrhea and ≥40 years of age) or physically incapable of becoming pregnant with documented permanent sterilization or history of infertility without anterior pregnancy.
- Women seeking for efficient contraception
- Current enrolment in any other clinical trial involving investigational drug, vaccine or medical device.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol specified assessments.
- Man
- Abnormal physical examination
- Abnormal spermogram
- Surgical sterilization
- History of urinary infections during the last 3 months
- History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, HPV) during the last 12 months
- STIs at time of screening
- Abnormal laboratory findings with clinical significance
- Allergy to gel polymer (polyoxyethylene-polyoxypropylene)
- Current enrolment in any other clinical trial involving investigational drug, vaccine or medical device.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol specified assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Descriptive Study On The Spermicidal Efficacy Of A Vaginal Gel Containing Or Not Sodium Lauryl Sulfate In Healthy Women And Their Male Partners
There is an urgent need to develop non-hormonal innovative preventive measures under the control of women that can prevent unintended pregnancy. Based on our experimental data, the use of a gel formulation containing SLS could represent a potent and safe topical vaginal spermicide. The impact of such a preventive tool on public health will be enormous. After successfully completing supportive Phase I/II safety trials, the next step is a prospective pilot clinical trial to evaluate the safety and effectiveness of our gel formulation as a spermicidal agent and for preventing unintended pregnancy in healthy women.
Read the detailed description
Study objectives (Outcomes):
The primary objective (Primary outcome) of this clinical trial is to evaluate the spermicidal efficacy in vitro and in post-coital test of gel formulation containing or not 2% SLS, when applied once intravaginally in healthy volunteers (women with their stable male sexual partners).
The secondary objective (Secondary outcome) of the study is to evaluate the safety and preliminary efficacy in preventing pregnancy of the gel formulation containing 2% SLS when used repeatedly before each sexual intercourse for a period of 3 months.
Study design: Pilot trial First phase- During volunteers screening for eligibility, male sexual partners will submit sperm samples; half of the sperm sample will be used for spermogram, and the other half of the sperm sample will be used (if normal spermogram) for in vitro testing of the spermicidal efficacy of the gel formulation components. If eligible, the man and his eligible female sex partner will be enrolled. Eligible women of the eligible male sex partners will have one vaginal gel application up to 30 min before planned sexual intercourse (vaginal penile penetration) with male ejaculating inside the vagina. Women will come to the clinic within a maximum of 12h period after the sexual intercourse for post-coital test. The gel must not be applied during menstrual period. The use of other vaginal products and male condom by participants is prohibited during the study period. A diary will be given to participants to record information concerning the internal use, if any, of any vaginal product (including tampons). This pilot trial will be performed in 1 center at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL.
Second phase- Couples agreeing to use the product repeatedly will continue to use the gel-SLS before each and every sexual intercourse, except during menstruation, for a period of 3 months. Women will report safety parameters after each vaginal use of the gel-SLS and will be followed regularly at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL.
- Conditions
- Contraception
- Being tested
- vaginal gel containing or not sodium lauryl sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal gel containing or not sodium lauryl sulfateOther
Also called Prevention
Prevention
| Study group | Role | What they receive |
|---|---|---|
| vaginal gel containing sodium lauryl sulfate | Experimental | Not described Receives: Other: vaginal gel containing or not sodium lauryl sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring motility of spermatozoides in vitro in presence of gel or gel-SLS, and in post-coital test after using gel or gel-SLS
- First, the motility of spermatozoides (progressive, non-progressive, or non-motile) in vitro in presence of gel, gel-SLS will be measured.
- Second, the motility of spermatozoides in post-coital test after single intravaginal application of gel or gel-SLS will be measured in women.
Measured: 3-6 months
Secondary outcomes (2)
Recording pregnancy occurrence after using gel-SLS
Recording pregnancy (no. of pregnant women) after the intravaginal application of the gel-SLS before each sexual intercourse for a period of 3 months.
Measured: 3 months
Recording adverse events (AE) after using gel-SLS
Recording AE (general and genital AE) after the intravaginal application of the gel-SLS before each sexual intercourse for a period of 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start23 Feb 2018
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
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.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot descriptive study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel G. Bergeron, MD FRCPC, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833115
- Sponsor's protocol ID
- CRI-INV.15
- Status last verified
- Feb 2021
- First submitted
- 22 Jan 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Descriptive Study On The Spermicidal Efficacy Of A Vaginal Gel Containing Or Not Sodium Lauryl Sulfate In Healthy Women And Their Male Partners
- ClinicalTrials.gov ID
- NCT03833115
- Acronym / sponsor ID
- CRI-INV.15
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 6 Feb 2019 (actual)
- 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.
There is an urgent need to develop non-hormonal innovative preventive measures under the control of women that can prevent unintended pregnancy. Based on our experimental data, the use of a gel formulation containing SLS could represent a potent and safe topical vaginal spermicide. The impact of such a preventive tool on public health will be enormous. After successfully completing supportive Phase I/II safety trials, the next step is a prospective pilot clinical trial to evaluate the safety and effectiveness of our gel formulation as a spermicidal agent and for preventing unintended pregnancy in healthy women.
Detailed description
Study objectives (Outcomes):
The primary objective (Primary outcome) of this clinical trial is to evaluate the spermicidal efficacy in vitro and in post-coital test of gel formulation containing or not 2% SLS, when applied once intravaginally in healthy volunteers (women with their stable male sexual partners).
The secondary objective (Secondary outcome) of the study is to evaluate the safety and preliminary efficacy in preventing pregnancy of the gel formulation containing 2% SLS when used repeatedly before each sexual intercourse for a period of 3 months.
Study design: Pilot trial First phase- During volunteers screening for eligibility, male sexual partners will submit sperm samples; half of the sperm sample will be used for spermogram, and the other half of the sperm sample will be used (if normal spermogram) for in vitro testing of the spermicidal efficacy of the gel formulation components. If eligible, the man and his eligible female sex partner will be enrolled. Eligible women of the eligible male sex partners will have one vaginal gel application up to 30 min before planned sexual intercourse (vaginal penile penetration) with male ejaculating inside the vagina. Women will come to the clinic within a maximum of 12h period after the sexual intercourse for post-coital test. The gel must not be applied during menstrual period. The use of other vaginal products and male condom by participants is prohibited during the study period. A diary will be given to participants to record information concerning the internal use, if any, of any vaginal product (including tampons). This pilot trial will be performed in 1 center at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL.
Second phase- Couples agreeing to use the product repeatedly will continue to use the gel-SLS before each and every sexual intercourse, except during menstruation, for a period of 3 months. Women will report safety parameters after each vaginal use of the gel-SLS and will be followed regularly at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot descriptive study
| Arm | Type | Receives |
|---|---|---|
| vaginal gel containing sodium lauryl sulfate | Experimental | Other: vaginal gel containing or not sodium lauryl sulfate |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Woman
- Healthy woman seeking to space or delay pregnancy aged between 18 and 49 years
- Sexually active
- Willing to give written informed consent to participate in the trial
- Normal physical and gynecological examination
Key exclusion criteria (27 listed)
- Woman
- Abnormal physical/gynecological examination
- Pregnant at enrolment
- Lactating or breastfeeding
- History of vaginitis during the last 3 months
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 |
|---|---|---|
| vaginal gel containing or not sodium lauryl sulfateAlso: PreventionPrevention | Other | vaginal gel containing sodium lauryl sulfate |
Primary outcome
Measuring motility of spermatozoides in vitro in presence of gel or gel-SLS, and in post-coital test after using gel or gel-SLS
Time frame: 3-6 months
* First, the motility of spermatozoides (progressive, non-progressive, or non-motile) in vitro in presence of gel, gel-SLS will be measured. * Second, the motility of spermatozoides in post-coital test after single intravaginal application of gel or gel-SLS will be measured in women.
2 secondary outcomes
Recording pregnancy occurrence after using gel-SLS
Time frame: 3 months
Recording adverse events (AE) after using gel-SLS
Time frame: 3 months
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 18 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal gel containing or not sodium lauryl sulfate in people with Contraception, run by Laval University at 1 site in Canada.
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 15 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
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?
Measuring motility of spermatozoides in vitro in presence of gel or gel-SLS, and in post-coital test after using gel or gel-SLS (time frame: 3-6 months). 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 18 Feb 2021.