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| Name | Class |
|---|---|
| The Family Planning Association of Hong Kong | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-ovulatory | Ulipristal acetate 30 mg single oral dose |
| |
| Post-ovulatory | Ulipristal acetate 30 mg single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Pregnancies Prevented (PPP) | one cycle (i.e. up to about 4 weeks) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hang Wun Raymond Li, MBBS, FRCOG | The University of Hong Kong | Principal Investigator |
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700 women were recruited at a community family planning clinic of the Family Plannng Association of Hong Kong, Hong Kong, between May 2011 and March 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-ovulatory | Ulipristal acetate 30 mg single oral dose 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. |
| FG001 | Post-ovulatory | Ulipristal acetate 30 mg single oral dose 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-ovulatory | Ulipristal acetate 30 mg single oral dose 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. |
| BG001 | Post-ovulatory |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Pregnancies Prevented (PPP) | Posted | Number | percentage of pregnancies prevented | one cycle (i.e. up to about 4 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-ovulatory | Ulipristal acetate 30 mg single oral dose 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor complaints | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond Li | The University of Hong Kong | +852 22553914 | raymondli@hku.hk |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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|
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) |
Ulipristal acetate 30 mg single oral dose 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Failure Rate | Number of subjects who got pregnant / Total number of subjects in the group | Posted | Number | percentage of participants | one cycle (i.e. up to about 4 weeks) |
|
|
|
|
| Secondary | 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 | Only subjects with follow-up information were included in this part of analysis | Posted | Median | Inter-Quartile Range | days | one cycle (i.e. up to about 4 weeks) |
|
|
|
|
| 0 |
| 364 |
| 117 |
| 364 |
| EG001 | Post-ovulatory | Ulipristal acetate 30 mg single oral dose 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. | 0 | 329 | 111 | 329 |
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