Eligibility Details:
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.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
