- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00411684
Safety and Efficacy of CDB-2914 for Emergency Contraception
27. august 2021 oppdatert av: HRA Pharma
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
1623
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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San Jose, California, Forente stater, 95126
- Planned Parenthood of Mar Monte
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Colorado
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Denver, Colorado, Forente stater, 80203
- Planned Parenthood of the Rocky Mountains
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Florida
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Miami, Florida, Forente stater
- Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
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Pembroke Pines, Florida, Forente stater
- Planned Parenthood of South Palm Beach, Pembroke Pines
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Indiana
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Bloomington, Indiana, Forente stater
- Planned Parenthood of Indiana
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Iowa
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Ames, Iowa, Forente stater
- Planned Parenthood of Greater Iowa
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Planned Parenthood of Maryland
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Planned Parenthood League of Massachusetts
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Michigan
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Ann Arbor, Michigan, Forente stater
- Planned Parenthood of Mid-Michigan Alliance
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Minnesota
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Minneapolis, Minnesota, Forente stater
- Planned Parenthood of Minnesota
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Ohio
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Cleveland, Ohio, Forente stater
- Planned Parenthood of Greater Cleveland
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Oregon
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Portland, Oregon, Forente stater, 97206
- Planned Parenthood of Columbia-Willamette
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater
- Planned Parenthood of SE Philadelphia
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Texas
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Austin, Texas, Forente stater
- Planned Parenthood of the Texas Capital Region
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Houston, Texas, Forente stater, 77004
- Planned Parenthood of Houston and Southeast Texas
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Utah
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Salt Lake City, Utah, Forente stater
- Planned Parenthood Association of Utah
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Washington
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Seattle, Washington, Forente stater, 98122
- Planned Parenthood of Western Washington
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Aged 18 years or more
- Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
- Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
- No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
- For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
- Willing to not use hormonal methods of contraception until study completion
- At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
- Able to provide informed consent in English
- Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks)
- Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained
Exclusion Criteria:
- One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
- All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
- Currently pregnant as confirmed by positive HSUP test performed at screening
- Currently breast-feeding
- Current use of hormonal contraception
- Use of hormonal emergency contraception since last menstrual period
- Current use of IUD
- Tubal ligation
- Partner with a vasectomy
- Unsure about the date of the last menstrual period
- Severe asthma insufficiently controlled by oral glucocorticoid
- Currently enrolled in any other trial of an investigational medicine
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: CDB-2914
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pregnancy Rate
Tidsramme: Up to 60 days after enrollment
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A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points:
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Up to 60 days after enrollment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
Tidsramme: within the menstrual cycle of the unprotected Intercourse
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Number of prevented pregnancies divided by the number of expected pregnancies
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within the menstrual cycle of the unprotected Intercourse
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Impact on Menstrual Bleeding Patterns
Tidsramme: within the menstrual cycle of the unprotected Intercourse
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Menstrual cycle length post treatment
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within the menstrual cycle of the unprotected Intercourse
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Frequencies of Subjects With Treatment Emergent Adverse Events
Tidsramme: 12-14 days after expected menses
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Most common related adverse events in ITT population.
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12-14 days after expected menses
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Paul Fine, MD, Planned Parenthood of Houston and Southeast Texas
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2006
Primær fullføring (Faktiske)
8. april 2008
Studiet fullført (Faktiske)
5. juni 2009
Datoer for studieregistrering
Først innsendt
13. desember 2006
Først innsendt som oppfylte QC-kriteriene
13. desember 2006
Først lagt ut (Anslag)
14. desember 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2914-005
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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