This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of product use, with a goal of 10 participants completing the study.
Each participant will be seen in approximately nine visits, over a period of 6-8 months, and will be contacted approximately 7 days after the final visit. Volunteers will be consented at Visit 1 and undergo procedures to confirm they are eligible to continue in the study. Each participant will undergo four postcoital test (PCT) cycles: 1. The first PCT cycle will be a baseline cycle, done without the use of any product, in order to demonstrate the participant's ability to undergo normal ovulatory events and to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus is also evaluated in this cycle. 2. Test PCT cycles will be carried out during the subsequent menstrual cycles using either the SILCS diaphragm with 3% N-9, the SILCS diaphragm with ContraGel, or the SILCS diaphragm alone following a sequence of randomized treatment. Cycles may need to be repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
27
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, United States
ProFamilia
Santo Domingo, Dominican Republic
Proportion of women with an average of fewer than 5 progressively motile sperm per high powered field (HPF) as a measure of preliminary effectiveness
Fewer than 5% progressively motile sperm per high power field is considered indicative of acceptable barrier function. Will be calculated separately for each test cycle.
Time frame: 2-3 hours following coitus
Per-women average number (across 9 HPFs) of progressively motile sperm per HPF as a measure of preliminary effectiveness.
Mean, median, standard deviation and IQR will be assessed for the baseline cycle and during each test PCT, across all women. Qualitative assessments of change from baseline, if any, will be based on medians and IQRs.
Time frame: 2-3 hours following coitus
Number of treatment emergent adverse experiences among female participants as a measure of safety
Urogenital, product-related, and/or serious AEs will be assessed
Time frame: Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months
Number of treatment emergent adverse experiences among male partners as a measure of safety
Urogenital, product-related, and/or serious AEs will be assessed
Time frame: Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.