- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh Medical Center
-
-
Virginia
-
Norfolk, Virginia, Stati Uniti, 23507
- Eastern Virginia Medical School
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: 1
SILCS with K-Y Jelly
|
|
Comparatore attivo: 2
SILCS with N-9
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
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.
Lasso di tempo: Within 2-3 hours of intercourse.
|
Within 2-3 hours of intercourse.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
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.
Lasso di tempo: Before and after intercourse
|
Before and after intercourse
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Jill Schwartz, MD, CONRAD
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A02-081
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Contraceptive Device
-
Tianjin Medical University General HospitalCompletatoMalattia di Devic | Sindrome di Devic | Neuromielite Ottica di Devic | Sindrome di Devic | Malattia devicaCina
-
Mayo ClinicAlexion PharmaceuticalsCompletatoNeuromielite Ottica | Malattia di DevicStati Uniti
-
Northwestern UniversityCompletato
-
Northwestern UniversityRitiratoNeuromielite Ottica | Malattia di Devic | Disturbo dello spettro NMOStati Uniti
-
Fu-Dong ShiCompletatoNeuromielite Ottica | Disturbi dello spettro della neuromielite ottica | Malattia di DevicCina
-
National Institute of Neurological Disorders and...Mayo ClinicSconosciutoEncefalomielite disseminata acuta | Sindrome di Devic | La variante di Marburg della sclerosi multipla | Sclerosi concentrica di Balo | Mielite trasversa acuta
Prove cliniche su SILCS and lubricant
-
CONRADCompletatoContraccezioneStati Uniti, Repubblica Dominicana
-
Bournemouth UniversityRoyal Bournemouth and Christchurch Hospitals NHS Foundation TrustCompletatoEffetto della formazioneRegno Unito
-
Dalarna UniversityUppsala University; The Swedish Research CouncilReclutamentoDemenza | Compromissione cognitiva lieve | Demenza, mista | Demenza di tipo Alzheimer | Compromissione cognitiva soggettiva | Demenza senileSvezia
-
Institut du Cancer de Montpellier - Val d'AurelleUniversity Hospital, Clermont-Ferrand; Laboratoire EPSYLON; Academic resource center...Completato
-
Samsung ElectronicsCompletatoInvecchiato | Adulti | Mezza età | Di età compresa tra 80 e oltreCorea, Repubblica di
-
Montefiore Medical CenterAmerican Psychological FoundationNon ancora reclutamentoDepressione postparto | Ansia post parto | Stress genitoriale | Relazioni genitore figlioStati Uniti
-
University Hospital, Clermont-FerrandNon ancora reclutamentoStress occupazionale | Comportamento sedentarioFrancia
-
University of Illinois at ChicagoReclutamentoAnziani saniStati Uniti
-
Institut de Cancérologie de la LoireCompletato
-
Indiana UniversityUniversity of South Florida; National Institute on Minority Health and Health... e altri collaboratoriCompletatoIntervento DECIDE modificato | Trattamento come consueto gruppo di curaStati Uniti