N/A
N=98
Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
Emergency Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01569737 ↗Enrolled (actual)
98
Serious AEs
—
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants Who Experienced Assessed Pregnancy Outcomes — 1; 0; 1; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ella (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- HRA Pharma
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Assessed Pregnancy Outcomes |
1; 0; 1; 0; 0; 93 | — |
Summary
The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.
Eligibility Criteria
- Pregnant women, exposed to ella during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy)
- Adolescents and/or adults in the USA, depending on the respective State law
Data sourced from ClinicalTrials.gov (NCT01569737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.