- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00561613
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
-
-
Virginia
-
Norfolk, Virginia, Estados Unidos, 23507
- Eastern Virginia Medical School
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador de Placebo: 1
SILCS with K-Y Jelly
|
|
Comparador Ativo: 2
SILCS with N-9
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
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.
Prazo: Within 2-3 hours of intercourse.
|
Within 2-3 hours of intercourse.
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
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.
Prazo: Before and after intercourse
|
Before and after intercourse
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Jill Schwartz, MD, CONRAD
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- A02-081
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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