Ulipristal Emergency Contraception Used Before or After Ovulation

NCT02517463 | Completed Results

• 1 other identifier: UW10-392
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Contraception

Keywords

Emergency contraception; ulipristal acetate; efficacy

Outcome Measures

Primary Outcomes (1)

• Percentage of Pregnancies Prevented (PPP)

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

Secondary Outcomes (2)

• Failure Rate

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

• Change in the Length of the Index Menstrual Cycle From Baseline

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

Study Arms (2)

Pre-ovulatory

Ulipristal acetate 30 mg single oral dose

Drug: Ulipristal acetate

Post-ovulatory

Ulipristal acetate 30 mg single oral dose

Drug: Ulipristal acetate

Interventions

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.

Also known as: Ella

Post-ovulatory; Pre-ovulatory

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Family Planning Association of Hong Kong: collaborator

MeSH Terms

Interventions

ulipristal acetate

Results Point of Contact

• Title: Dr. Raymond Li
• Organization: The University of Hong Kong

raymondli@hku.hk

+852 22553914

Study Officials

• Hang Wun Raymond Li, MBBS, FRCOG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 7, 2015
• Study Start: May 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2017-10