Ulipristal Acetate for Emergency Birth Control

Overseen By Women's Health Research Unit Department of OB/GYN

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must not be taking: Hormonal contraceptives, NSAIDs, CYP3A4 drugs

Disqualifiers: Pregnancy, Breastfeeding, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

140 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.

Will I have to stop taking my current medications?

The trial requires that you stop using drugs that interfere with the study medication within 2 weeks of enrollment. This includes drugs that affect how the body processes the study drug.

What data supports the effectiveness of the drug Ulipristal Acetate for emergency birth control?

Ulipristal acetate is effective for emergency contraception when taken within 120 hours after unprotected sex, as it delays or inhibits ovulation. It is more effective than levonorgestrel, especially when taken beyond 72 hours, and has a similar safety profile. ^{1 2 3 4 5}

Is ulipristal acetate safe for use in humans?

Ulipristal acetate is generally well tolerated and considered safe for use as emergency contraception, with side effects similar to those of levonorgestrel, another emergency contraceptive. It is also effective and well tolerated for treating uterine fibroids, with fewer hot flashes compared to other treatments. ^{1 2 3 4 5}

How does the drug ulipristal acetate differ from other emergency contraception options?

Ulipristal acetate is unique because it can be taken up to 5 days (120 hours) after unprotected intercourse, offering a longer window than levonorgestrel, which is effective only up to 3 days (72 hours). It works by delaying or inhibiting ovulation and has been shown to be more effective than levonorgestrel, especially when taken later in the 5-day period. ^{1 2 3 4 6}

Research Team

Alison B Edelman, MD, MPH

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for generally healthy women aged 18-40 with regular menstrual cycles, who are not pregnant, seeking pregnancy, or breastfeeding. Participants should have no known allergy to the study medication and must not be using certain drugs that affect its metabolism.

Inclusion Criteria

I am a healthy woman between 18 and 40 years old.

Women with regular menses (every 21-35 days) experiencing ovulatory cycles proven by a single progesterone level of 3 ng/mL or greater during the luteal phase of the screening cycle

Exclusion Criteria

I regularly take NSAIDs for pain or inflammation.

Smoking

Pregnant, seeking pregnancy, or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ulipristal acetate 30mg with pharmacokinetic and pharmacodynamics testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for follicular rupture and UPA concentration

5 days

1 visit (in-person), additional monitoring

Follow-up

Participants are monitored for follicular rupture over one menstrual cycle

up to 30 days

Treatment Details

Interventions

• Ulipristal acetate

Trial Overview The study investigates why emergency contraceptives like Ulipristal acetate work for some but fail for others. It's looking into whether genetic differences influence how well these contraceptives prevent pregnancy after unprotected sex.

Participant Groups

Group I: Active CYP3A5 Allele Active Control 1 Intervention

Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles

Group II: Inactive CYP3A5 Allele Active Control 1 Intervention

Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles

Ulipristal acetate is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Ella for:

• Emergency contraception

Approved in Canada as Fibristal for:

• Emergency contraception
• Uterine fibroids

Approved in European Union as EllaOne for:

• Emergency contraception

Approved in European Union as Esmya for:

• Uterine fibroids

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Ulipristal acetate is an effective emergency contraception option that can be taken up to 120 hours after unprotected sex, inhibiting or delaying ovulation, and is well tolerated by users.

In clinical trials, ulipristal acetate was found to be equally effective as levonorgestrel within 72 hours but showed superior effectiveness when taken later, making it a valuable option for women needing emergency contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulipristal acetate: a review of its use in emergency contraception. McKeage, K., Croxtall, JD.[2021]

Ulipristal acetate is effective as emergency contraception for women who take it 48 to 120 hours after unprotected intercourse, with a pregnancy rate of only 2.1%, which is lower than expected rates, indicating its efficacy over time.

The treatment is generally well-tolerated, with most side effects being mild to moderate, such as headache and nausea, and it does not significantly alter menstrual bleeding duration, although it may increase cycle length by an average of 2.8 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Fine, P., Mathé, H., Ginde, S., et al.[2021]

Ulipristal acetate is a new and effective emergency contraceptive that can be taken up to 5 days after unprotected intercourse, showing a 42% lower pregnancy risk than levonorgestrel within 72 hours and 65% lower within the first 24 hours.

It is more effective than the older levonorgestrel method in delaying ovulation and preventing pregnancies, with mild side effects similar to those of levonorgestrel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on emergency contraception. Fine, PM.[2013]

Ulipristal acetate is an effective emergency contraceptive that can be taken up to 120 hours after unprotected intercourse, showing at least equal efficacy to levonorgestrel in reducing pregnancy rates based on Phase 3 clinical trials.

Common side effects include headache, breast tenderness, nausea, and abdominal pain, but ulipristal's prescription-only status may affect accessibility and insurance coverage considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulipristal acetate for emergency contraception. Snow, SE., Melillo, SN., Jarvis, CI.[2017]

Ulipristal acetate is an effective treatment for moderate to severe uterine fibroid symptoms, approved for both preoperative and intermittent use in women of reproductive age.

It is comparable in efficacy to intramuscular leuprolide acetate for preoperative treatment but has a lower incidence of hot flashes, making it a well-tolerated option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulipristal Acetate: A Review in Symptomatic Uterine Fibroids. Garnock-Jones, KP., Duggan, ST.[2019]

Ulipristal acetate (ellaOne) is a new oral emergency contraceptive that can be taken up to 120 hours (5 days) after unprotected intercourse, offering a longer window for effective use compared to the previously available options.

This new option provides women in the UK with an additional choice for emergency contraception, potentially improving access and effectiveness in preventing unintended pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulipristal - a new emergency contraceptive pill. [2012]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Ulipristal acetate: a review of its use in emergency contraception. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Update on emergency contraception. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Ulipristal acetate for emergency contraception. [2017]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Ulipristal Acetate: A Review in Symptomatic Uterine Fibroids. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Ulipristal - a new emergency contraceptive pill. [2012]