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Completed

NCT Number: NCT02517463

Ulipristal Emergency Contraception Used 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.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulipristal Acetate

Drug

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

Primary outcomes

  1. Percentage of Pregnancies Prevented (PPP)

    Time frame: one cycle (i.e. up to about 4 weeks)

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • The Family Planning Association of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2015
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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