Ulipristal Emergency Contraception Used Before or After Ovulation

October 24, 2017 updated by: Dr. Hang Wun Raymond Li, The University of Hong Kong

Observational Study on the Clinical Efficacy of Ulipristal for Emergency Contraception When Administered Before or After Ovulation

This was a prospective, open-label, single-drug, uncontrolled, observational clinical study.

Women attending the Family Planning Association of Hong Kong (FPAHK) for emergency contraception within 120 hours of UPSI were recruited. Subjects were recruited from both the Birth Control Clinics and Youth Health Care Centres of the FPAHK.

Depending on the timing in relation to ovulation in the current menstrual cycle at the time of presentation, the women were classified into two groups:

Group 1: pre-ovulatory Group 2: post-ovulatory

After counseling and obtaining informed consent, eligible subjects received a single dose of ulipristal acetate 30 mg (ellaOne®) under direct supervision. A baseline blood test for hormonal profile (LH, oestradiol and progesterone) and ultrasound scan for ovarian follicle assessment were carried out by a designated doctor or research nurse at the clinic visit.

The subjects were advised not to have further acts of coitus before the return of menstruation. They were given a diary chart to record vaginal spotting and bleeding, possible side effects and further acts of intercourse, if any, and the contraceptive method used. A follow-up appointment were be arranged about 1-2 weeks after the expected next menstruation. Any events of unplanned pregnancy and adverse effects were recorded for analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

A total of 700 women attending the Family Planning Association of Hong Kong for emergency contraception who fulfilled the inclusion criteria and not meeting the exclusion criteria were recruited.

Description

Inclusion Criteria:

  1. Healthy women aged 18 years or above;
  2. Regular menstrual cycles (every 21-35 days) within the past three cycles;
  3. Requesting emergency contraception within 120 h of a single act of unprotected intercourse in the current menstrual cycle;
  4. Willing to abstain from further acts of unprotected intercourse and;
  5. Available for follow-up over the next 6 weeks

Exclusion Criteria:

  1. Post-abortion or postpartum patients whose period had not yet returned
  2. Regular use of prescription drugs before admission to the study and
  3. Intercourse during the treatment cycle more than 120 h before admission into the study.
  4. Found pregnant at the time of presentation
  5. Breastfeeding women
  6. Women who have been sterilized (or partner being sterilized) or have intrauterine contraceptive device in-situ
  7. Uncertain about the date of the last menstrual period
  8. Women who had used hormonal contraceptive in the current or past one cycle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-ovulatory
Ulipristal acetate 30 mg single oral dose
Drug: Ulipristal acetate
This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
Other Names:
  • Ella
Post-ovulatory
Ulipristal acetate 30 mg single oral dose
Drug: Ulipristal acetate
This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
Other Names:
  • Ella

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Pregnancies Prevented (PPP)
Time Frame: one cycle (i.e. up to about 4 weeks)
one cycle (i.e. up to about 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure Rate
Time Frame: one cycle (i.e. up to about 4 weeks)
Number of subjects who got pregnant / Total number of subjects in the group
one cycle (i.e. up to about 4 weeks)
Change in the Length of the Index Menstrual Cycle From Baseline
Time Frame: one cycle (i.e. up to about 4 weeks)
shortening or lengthening of the index menstrual cycle compared to the previous menstrual pattern of the subject
one cycle (i.e. up to about 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

The Family Planning Association of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW10-392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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