Ulipristal Emergency Contraception Used Before or After Ovulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Ulipristal acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-ovulatory<br>Ulipristal acetate 30 mg single oral dose | Drug: Ulipristal acetate<br>* 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.<br>* Other names: Ella;|
| Post-ovulatory<br>Ulipristal acetate 30 mg single oral dose | Drug: Ulipristal acetate<br>* 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.<br>* Other names: Ella;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure Rate | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency contraception, ulipristal acetate, efficacy