Ulipristal Emergency Contraception Used Before or After Ovulation

NCT ID: NCT02517463

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre-ovulatory

Ulipristal acetate 30 mg single oral dose

Ulipristal acetate

Intervention Type: 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.

Post-ovulatory

Ulipristal acetate 30 mg single oral dose

Ulipristal acetate

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ella

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Family Planning Association of Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Hang Wun Raymond Li

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hang Wun Raymond Li, MBBS, FRCOG

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Other Identifiers

UW10-392

Identifier Type: -

Identifier Source: org_study_id