ContraceptionNCT01107106
Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women
An observational study of Contraception, run by HRA Pharma at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- ellaOne® (ulipristal acetate)
- Type of treatment
- Pill or oral medicine
- How many people
- 579 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden
Who may be able to join
- Having received ellaOne® as emergency contraception at the clinical site
- Postmenarcheal adolescents or adult women
- Willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly
- Willing to provide information on pregnancy outcome / delivery and newborn's health at delivery
- Able to provide written informed consent
- Willing to not participate in a clinical trial before the end of study participation
Who cannot join
- Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
PPRM Central clinic
Denver, Colorado, CO 80218
PPRM Southwest clinic
Lakewood, Colorado, CO 80232
Elizabeth Blackwell Health Center
Philadelphia, Pennsylvania, PA 19107
Locust Health Center
Philadelphia, Pennsylvania, PA19107
Sweden1 site
Dept of Women & Child Health - Karolinska University Hospital
Stockholm
About this study
Official title: Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult 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.
- Conditions
- Contraception
- Being tested
- ellaOne® (ulipristal acetate)
- Keywords
- Contraceptive Methods, Female Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ellaOne® (ulipristal acetate)Drug
Also called ellaOne®
one single oral dose (30 mg tablet)
ellaOne® (ulipristal acetate)Drug
Also called ellaOne®
one single oral dose (30 mg tablet)
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | 250 postmenarcheal adolescent girls Receives: Drug: ellaOne® (ulipristal acetate) | |
| Adults | 250 adult women Receives: Drug: ellaOne® (ulipristal acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
Collection of adverse events, concomitant treatments, length of menstrual cycle, and vaginal bleeding/spotting through follow-up contacts and a diary completed by the patient
Measured: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)
Secondary outcomes (1)
Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception
Measured: Two months (i.e. during two menstrual cycles following ellaOne® intake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107106
- Sponsor's protocol ID
- 2914-010
- Other IDs
- 2009-017771-21, 2009
- Status last verified
- May 2013
- First submitted
- 12 Apr 2010
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult Women
- ClinicalTrials.gov ID
- NCT01107106
- Acronym / sponsor ID
- 2914-010
- Conditions
- Contraception
- Keywords
- Contraceptive Methods, Female Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Drug: ellaOne® (ulipristal acetate)250 postmenarcheal adolescent girls |
| Adults | – | Drug: ellaOne® (ulipristal acetate)250 adult women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden
Key inclusion criteria (6 listed)
- Having received ellaOne® as emergency contraception at the clinical site
- Postmenarcheal adolescents or adult women
- Willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly
- Willing to provide information on pregnancy outcome / delivery and newborn's health at delivery
- Able to provide written informed consent
Key exclusion criteria (1 listed)
- Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ellaOne® (ulipristal acetate)Also: ellaOne®one single oral dose (30 mg tablet) | Drug | Adolescents |
| ellaOne® (ulipristal acetate)Also: ellaOne®one single oral dose (30 mg tablet) | Drug | Adults |
Primary outcome
Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
Time frame: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)
Collection of adverse events, concomitant treatments, length of menstrual cycle, and vaginal bleeding/spotting through follow-up contacts and a diary completed by the patient
1 secondary outcome
Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception
Time frame: Two months (i.e. during two menstrual cycles following ellaOne® intake)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by HRA Pharma at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception (time frame: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.