Postcoital Testing of the SILCS Diaphragm
This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at risk for pregnancy due to previous female sterilization. The male partners of the participants were consented to participate in the study. The clinician evaluating the cervical mucus for midcycle characteristics and presence of sperm was blinded as to gel used. The product tested was the SILCS diaphragm with Gynol II (spermicide) and the SILCS diaphragm with KY Jelly (lubricant). The sequence of diaphragm and gel use was determined by randomization. The study was conducted at two centers, Magee-Womens Hospital in Pittsburgh, Pennsylvania and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in Norfolk, Virginia.
The study consisted of a screening visit, a baseline cycle, and up to 2 cycles of post-coital tests (PCTs) for a total of 7 visits. The first PCT was a baseline PCT, performed without the use of any product, in order to demonstrate the subject's ability to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus was evaluated in this cycle. Test PCTs were carried out during the second and third menstrual cycle using either the SILCS diaphragm with N-9 or the SILCS diaphragm with lubricant. Cycles were repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens; thus, some women may undergo more than three PCTs. An additional test cycle with a modified polymer spring device was performed in a subset of participants.
Colposcopy was performed during the mucus check and post-coital test visits in all three cycles in order to document the baseline condition of the vagina and cervix pre- and post-intercourse and, in test cycles, to note the effect of product.
Vaginal samples were taken from the posterior fornix of the vagina and the cervical os at each visit during the baseline and test cycles to measure for the presence of PSA.
Other: SILCS and lubricant
Other: SILCS and spermicide
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase I Postcoital Testing and Safety Study of the SILCS Diaphragm, Prototype VI|
- Percentage of women with any sperm in the cervical mucus, with ≥ 5 progressively motile sperm per high power field (HPF), and the average number of progressively motile sperm per HPF. [ Time Frame: Within 2-3 hours of intercourse. ]
- Symptoms and signs of irritation of the external genitalia, cervix, and vagina before and after intercourse and by gel product. The handling, fit, and general acceptability of the SILCS diaphragm was assessed. [ Time Frame: Before and after intercourse ]
|Study Start Date:||August 2003|
|Study Completion Date:||October 2004|
Placebo Comparator: 1
SILCS with K-Y Jelly
|Other: SILCS and lubricant|
Active Comparator: 2
SILCS with N-9
|Other: SILCS and spermicide|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Virginia|
|Eastern Virginia Medical School|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Jill Schwartz, MD||CONRAD|