Title

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

    N/A
  • Study Type

    Observational
  • Intervention/Treatment

    ulipristal ...
  • Study Participants

    700
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 Started
May 31
2011
Primary Completion
Apr 30
2014
Study Completion
Apr 30
2014
Results Posted
Jul 30
2018
Last Update
Jul 30
2018

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

Pre-ovulatory None

Ulipristal acetate 30 mg single oral dose

Post-ovulatory None

Ulipristal acetate 30 mg single oral dose

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Summary

Pre-ovulatory

Post-ovulatory

All Events

Event Type Organ System Event Term Pre-ovulatory Post-ovulatory

Percentage of Pregnancies Prevented (PPP)

Pre-ovulatory

77.5
percentage of pregnancies prevented

Post-ovulatory

36.9
percentage of pregnancies prevented

Failure Rate

Number of subjects who got pregnant / Total number of subjects in the group

Pre-ovulatory

1.4
percentage of participants

Post-ovulatory

2.1
percentage of participants

Change in the Length of the Index Menstrual Cycle From Baseline

shortening or lengthening of the index menstrual cycle compared to the previous menstrual pattern of the subject

Pre-ovulatory

3.0
days (Median)
Inter-Quartile Range: 0.0 to 6.0

Post-ovulatory

-1.0
days (Median)
Inter-Quartile Range: -3.0 to 1.0

Total

693
Participants

Age, Continuous

32
years (Median)
Inter-Quartile Range: 28.0 to 38.0

Age, Categorical

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Pre-ovulatory

Post-ovulatory

Drop/Withdrawal Reasons

Pre-ovulatory

Post-ovulatory