Postcoital Testing of the SILCS Diaphragm
A Phase I Postcoital Testing and Safety Study of the SILCS Diaphragm, Prototype VI
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh Medical Center
-
-
Virginia
-
Norfolk, Virginia, Stany Zjednoczone, 23507
- Eastern Virginia Medical School
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Female Participants
- 18-45 years old (inclusive)
- In good general health based on medical history & physical exam
- Previous bilateral tubal ligation or salpingectomy
- Regular menstrual cycles of 24-35 days (inclusive)
- Negative urine pregnancy test at admission
- Not currently breast feeding
- No significant gynecological abnormalities
- Normal cervical Papanicolaou smear within 6 months preceding enrollment
- In a stable relationship with only one sexual partner
- Willing to undergo at least three PCTs
- Willing to abstain from intercourse and use of vaginal products
- Willing to use condoms from day 1 of each menstrual cycle until midcycle
Male Participants
- Age 18 years and older
- Able and willing to provide written informed consent
- Willing to engage in intercourse with and without condoms
Exclusion Criteria:
Female Participants
- History in subject of allergy to study products
- Positive wet mount for Trichomonas vaginalis
- History of any STD within 6 months of enrollment
- Device does not appropriately fit volunteer, as determined by clinician
- Inability to insert, position, and/or remove study device
- Participation in another study within 30 days prior to enrollment
Male Participants
- History of allergy to study products
- History of vasectomy
- In the six months prior to study, diagnosed with or treated for any STI
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Komparator placebo: 1
SILCS with K-Y Jelly
|
|
|
Aktywny komparator: 2
SILCS with N-9
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
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.
Ramy czasowe: Within 2-3 hours of intercourse.
|
Within 2-3 hours of intercourse.
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
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.
Ramy czasowe: Before and after intercourse
|
Before and after intercourse
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Jill Schwartz, MD, CONRAD
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- A02-081
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .