Contraception
Conditions
Keywords
Emergency contraception, ulipristal acetate, efficacy
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.
Interventions
DRUGUlipristal 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.
Sponsors
The Family Planning Association of Hong Kong
The University of Hong Kong
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Pregnancies Prevented (PPP) | one cycle (i.e. up to about 4 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure Rate | one cycle (i.e. up to about 4 weeks) | Number of subjects who got pregnant / Total number of subjects in the group |
| Change in the Length of the Index Menstrual Cycle From Baseline | 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 |
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 364 |
| 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. | 329 |
| Total | 693 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
Baseline characteristics
| Characteristic | Post-ovulatory | Total | Pre-ovulatory |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 329 Participants | 693 Participants | 364 Participants |
| Age, Continuous | 34 years | 32 years | 31 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 322 Participants | 677 Participants | 355 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 16 Participants | 9 Participants |
| Region of Enrollment Hong Kong | 329 participants | 693 participants | 364 participants |
| Sex: Female, Male Female | 329 Participants | 693 Participants | 364 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 117 / 364 | 111 / 329 |
| serious Total, serious adverse events | 0 / 364 | 0 / 329 |
Outcome results
Primary
Percentage of Pregnancies Prevented (PPP)
Time frame: one cycle (i.e. up to about 4 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-ovulatory | Percentage of Pregnancies Prevented (PPP) | 77.5 percentage of pregnancies prevented |
| Post-ovulatory | Percentage of Pregnancies Prevented (PPP) | 36.9 percentage of pregnancies prevented |
p-value: <0.0001Chi-squared
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
Time frame: one cycle (i.e. up to about 4 weeks)
Population: Only subjects with follow-up information were included in this part of analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-ovulatory | Change in the Length of the Index Menstrual Cycle From Baseline | 3 days |
| Post-ovulatory | Change in the Length of the Index Menstrual Cycle From Baseline | -1 days |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Failure Rate
Number of subjects who got pregnant / Total number of subjects in the group
Time frame: one cycle (i.e. up to about 4 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-ovulatory | Failure Rate | 1.4 percentage of participants |
| Post-ovulatory | Failure Rate | 2.1 percentage of participants |
p-value: 0.564Fisher Exact