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

Fecha de inicio: 23 de febrero de 2018

Inclusion Criteria: Woman 1. Healthy woman seeking to space or delay pregnancy aged between 18 and 49 years 2. Sexually active 3. Willing to give written informed consent to participate in the trial 4. Normal physical and gynecological examination 5. Negative urine pregnancy test at screening 6. Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside the vagina 7. 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 1. Healthy man aged 18 years and older 2. Sexually active 3. Normal spermogram at inclusion 4. Normal physical examination 5. Willing to give written informed consent to participate in the trial 6. Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside the vagina for post coital test. Exclusion Criteria: Woman 1. Abnormal physical/gynecological examination 2. Pregnant at enrolment 3. Lactating or breastfeeding 4. History of vaginitis during the last 3 months 5. History of using vaginal medications during the last 3 months 6. History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, vulvo-vaginal or cervical HPV) during the last 12 months 7. STIs at time of screening 8. Abnormal laboratory findings with clinical significance 9. Allergy to applicator material (polyethylene), to gel polymer (polyoxyethylene-polyoxypropylene) 10. History of toxic shock syndrome (TSS) 11. 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) 12. 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. 13. Women seeking for efficient contraception 14. Current enrolment in any other clinical trial involving investigational drug, vaccine or medical device. 15. 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 1. Abnormal physical examination 2. Abnormal spermogram 3. Surgical sterilization 4. History of urinary infections during the last 3 months 5. History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, HPV) during the last 12 months 6. STIs at time of screening 7. Abnormal laboratory findings with clinical significance 8. Allergy to gel polymer (polyoxyethylene-polyoxypropylene) 9. Current enrolment in any other clinical trial involving investigational drug, vaccine or medical device. 10. 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.