Ulipristal Emergency Contraception Used Before or After Ovulation

An observational study of Contraception, run by The University of Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Contraception
What is being tested?: Ulipristal acetate
Type of treatment: Pill or oral medicine
How many people: 700 participants
Where: No sites listed yet
Study dates: May 2011to Apr 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

About this study

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

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
Being tested: Ulipristal acetate
Keywords: Emergency contraception, ulipristal acetate, efficacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ulipristal acetateDrug
Also called Ella
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.

Study groups in NCT02517463
Study group	Role	What they receive
Pre-ovulatory		Ulipristal acetate 30 mg single oral dose Receives: Drug: Ulipristal acetate
Post-ovulatory		Ulipristal acetate 30 mg single oral dose Receives: Drug: Ulipristal acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Pregnancies Prevented (PPP)
Measured: one cycle (i.e. up to about 4 weeks)

Secondary outcomes (2)

Failure Rate
Number of subjects who got pregnant / Total number of subjects in the group
Measured: 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
Measured: one cycle (i.e. up to about 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Apr 2014

First posted7 Aug 2015 (estimated)
Study startMay 2011
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ContraceptionStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 700 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02517463
Sponsor's protocol ID: UW10-392
Status last verified: Oct 2017
First submitted: 3 Aug 2015
Last updated: 30 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study on the Clinical Efficacy of Ulipristal for Emergency Contraception When Administered Before or After Ovulation
ClinicalTrials.gov ID: NCT02517463
Acronym / sponsor ID: UW10-392
Conditions: Contraception
Keywords: Emergency contraception, ulipristal acetate, efficacy
Study type: Observational
Recruitment status: Completed
Enrolment: 700 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Collaborators: The Family Planning Association of Hong Kong
Study start: May 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 7 Aug 2015 (estimated)
Results: Posted 30 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This was a prospective, open-label, single-drug, uncontrolled, observational clinical study.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pre-ovulatory	–	Drug: Ulipristal acetateUlipristal acetate 30 mg single oral dose
Post-ovulatory	–	Drug: Ulipristal acetateUlipristal acetate 30 mg single oral dose

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ulipristal acetateAlso: EllaThis 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.	Drug	Post-ovulatory, Pre-ovulatory

Primary outcome

Percentage of Pregnancies Prevented (PPP)
Time frame: one cycle (i.e. up to about 4 weeks)

2 secondary outcomes

Failure Rate
Time frame: one cycle (i.e. up to about 4 weeks)
Change in the Length of the Index Menstrual Cycle From Baseline
Time frame: one cycle (i.e. up to about 4 weeks)

Results and safety

Results posted to the registry on 30 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-ovulatory	369	364
Post-ovulatory	331	329

Primary outcome: Percentage of Pregnancies Prevented (PPP)

Time frame: one cycle (i.e. up to about 4 weeks). Number. Unit: percentage of pregnancies prevented

Measure	Pre-ovulatory n = 364	Post-ovulatory n = 329
Value	77.5	36.9

Pre-ovulatory vs Post-ovulatory: p <0.0001, Chi-squared

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-ovulatory	0 of 364 (0%)	117 of 364 (32.1%)	Not reported
Post-ovulatory	0 of 329 (0%)	111 of 329 (33.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Contraception

Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hang Wun Raymond Li, MBBS, FRCOG principal investigator

The University of Hong Kong

Questions about this trial

What is this clinical trial studying?

An observational study of Contraception, run by The University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Pregnancies Prevented (PPP) (time frame: one cycle (i.e. up to about 4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02517463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.