Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED

Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women

NCT01107106 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.

Conditions Studied

Interventions

  • DRUG ellaOne® (ulipristal acetate)

Study Locations (6)

Colorado

  • PPRM Central clinic — Denver
  • PPRM Southwest clinic — Lakewood

Pennsylvania

  • Elizabeth Blackwell Health Center — Philadelphia
  • Locust Health Center — Philadelphia

Other

  • Dept of Women & Child Health - Karolinska University Hospital — Stockholm
  • Brook clinic — Belfast

Trial Details

FieldValue
Enrollment Target 579 participants
Start Date 2010-05
Est. Completion 2013-02

Sponsor

HRA Pharma

3 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01107106

The ClinicalTrials.gov registry entry for NCT01107106 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 579 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HRA Pharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention — of which ellaOne® (ulipristal acetate) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01107106 reports 6 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Pennsylvania, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01107106 about?

NCT01107106 is a clinical study titled "Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women". The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.

What is the current status of trial NCT01107106?

This trial is currently completed. The enrollment target is 579 participants. The study started on 2010-05. Estimated completion is 2013-02.

What conditions does trial NCT01107106 study?

This clinical trial studies the following conditions: Contraception. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01107106?

The interventions under investigation include: ellaOne® (ulipristal acetate) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01107106?

This trial is sponsored by HRA Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01107106 being conducted?

This trial has 6 study locations across Colorado, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial