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

NCT01107106 | Completed

• 2 other identifiers: 2914-0102009-017771-21
• Study Type: observational
• Target: 579
• Locations: 3 countries
• Sites: 6

Brief 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

Contraception

Keywords

Contraceptive Methods; Female Contraception

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Two months (i.e. during two menstrual cycles following ellaOne® intake)

Study Arms (2)

Adolescents

250 postmenarcheal adolescent girls

Drug: ellaOne® (ulipristal acetate)

Adults

250 adult women

Drug: ellaOne® (ulipristal acetate)

Interventions

ellaOne® (ulipristal acetate) DRUG

one single oral dose (30 mg tablet)

Also known as: ellaOne®

Adolescents

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden

You may qualify if:

• 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

You may not qualify if:

• Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)

Sponsors & Collaborators

• HRA Pharma: lead

Study Sites (6)

PPRM Central clinic

Denver, Colorado, CO 80218, United States

Location

PPRM Southwest clinic

Lakewood, Colorado, CO 80232, United States

Location

Elizabeth Blackwell Health Center

Philadelphia, Pennsylvania, PA 19107, United States

Location

Locust Health Center

Philadelphia, Pennsylvania, PA19107, United States

Location

Dept of Women & Child Health - Karolinska University Hospital

Stockholm, Sweden

Location

Brook clinic

Belfast, BT12DX, United Kingdom

Location

MeSH Terms

Interventions

ulipristal acetate

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 20, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

GB (1); US (4); SE (1)