Spermicidal Efficacy Of A Vaginal Gel

NCT03833115 | Completed

• 1 other identifier: CRI-INV.15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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.

  3-6 months

Secondary Outcomes (2)

• Recording pregnancy occurrence after using gel-SLS

  3 months

• Recording adverse events (AE) after using gel-SLS

  3 months

Study Arms (1)

vaginal gel containing sodium lauryl sulfate

EXPERIMENTAL

Other: vaginal gel containing or not sodium lauryl sulfate

Interventions

vaginal gel containing or not sodium lauryl sulfate OTHER

Prevention

Also known as: Prevention

vaginal gel containing sodium lauryl sulfate

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: vaginal product for women and their male sexual partners
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Michel Bergeron

Québec, G1V4G2, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot descriptive study

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 6, 2019
• Study Start: February 23, 2018
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CA (1)