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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why oral emergency contraception fails for some women but not others. Researchers are testing whether genetic differences, specifically the presence or absence of certain CYP3A5 alleles (gene variations affecting drug metabolism), influence this outcome. Participants will receive a dose of ulipristal acetate, an emergency contraceptive, to observe their body's response. Women who are generally healthy, aged 18-40, and have regular menstrual cycles may be suitable for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

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 is the safety track record for Ulipristal acetate?

Research has shown that ulipristal acetate is generally safe and well-tolerated as an emergency contraceptive. One study found it safe to take within 48 to 120 hours after unprotected sex. Most people do not experience major side effects. Common but mild side effects include headache, nausea, and stomach pain, while serious side effects are rare.

Since the FDA has approved ulipristal acetate for emergency contraception, it has undergone thorough safety studies. However, limited information exists on its use in people with different medical conditions or genetic backgrounds. This trial aims to explore those genetic differences and their effects, but current evidence supports the safety of ulipristal acetate for general use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard emergency contraceptive pills that often contain levonorgestrel, Ulipristal acetate works differently by targeting the progesterone receptor to delay or prevent ovulation. This unique mechanism allows Ulipristal acetate to be effective even when taken closer to ovulation, offering a broader window of efficacy compared to other options. Additionally, Ulipristal acetate is a one-time oral dose, making it both convenient and easy to use. Researchers are excited about its potential to provide more reliable emergency contraception, especially for individuals with specific genetic markers like the CYP3A5 allele, which can affect drug metabolism and efficacy.

What is the effectiveness track record for Ulipristal acetate as emergency birth control?

Research shows that ulipristal acetate is a strong option for emergency birth control. In a large study with over 1,500 participants, only 1.9% became pregnant after taking ulipristal acetate, compared to an expected 5.7%. Another study found a pregnancy rate of just 1.2% among women who used it. These findings suggest that ulipristal acetate greatly lowers the chance of pregnancy when used as emergency contraception. It appears to work better than some other options, especially if taken within a few days after unprotected sex. Overall, ulipristal acetate is a dependable choice for preventing pregnancy in emergency situations.

In this trial, participants will receive a single 30mg dose of ulipristal acetate. Researchers will conduct pharmacokinetic and pharmacodynamic testing to assess its effectiveness in individuals with active and inactive CYP3A5 alleles. ^{6 7 8 9 10}

Who Is on the Research Team?

Alison B Edelman, MD, MPH

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 (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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782425000897

Hormonal contraception after use of ulipristal acetate as ... Hormonal contraception use immediately or soon after UPA may decrease UPA's ability to delay ovulation. The certainty of evidence ranged from moderate to very ...

2. ti.ubc.ca ti.ubc.ca/2024/07/26/efficacy-and-safety-of-ulipristal-compared-with-levonorgestrel-for-emergency-oral-contraception/

Efficacy and safety of ulipristal compared with ... In 1899 women who received emergency contraception within 120 h after sexual intercourse, pregnancy rates were estimated as 1·6% and 2·6% in the ...

3. cdc.gov cdc.gov/contraception/hcp/usspr/emergency-contraception.html

Emergency Contraception UPA and LNG ECPs have similar effectiveness when taken within 3 days after unprotected sexual intercourse; however, UPA has been observed to be ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3138379/

Ulipristal Acetate (ella): A Selective Progesterone Receptor ... In the ITT population (N = 1,533), the observed pregnancy rate was 1.9% (95% CI, 1.3%–2.8%), compared with an expected pregnancy rate of 5.7%. Overall, the use ...

5. who.int who.int/news-room/fact-sheets/detail/emergency-contraception

Emergency contraception A meta-analysis of two studies showed that women who used ECPs with UPA had a pregnancy rate of 1.2%. Studies have shown that ECPs with LNG had ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26546020/

Safety data for levonorgestrel, ulipristal acetate and Yuzpe ... Evidence on safety of ECPs among women with characteristics or medical conditions listed within WHO and CDC family planning guidance is limited.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf

Ella (ulipristal acetate) tablet - accessdata.fda.gov An open-label study provided the primary data to support the efficacy and safety of ulipristal acetate for emergency contraception when taken 48 to 120 hours ...

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/78413

Safety data for levonorgestrel, ulipristal acetate and Yuzpe ... Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception. Tara C. Jatlaoui*, Halley Riley, and Kathryn M. Curtis

9. mayoclinic.org mayoclinic.org/drugs-supplements/ulipristal-oral-route/description/drg-20074458

Ulipristal (oral route) - Side effects & dosage Ulipristal is an emergency contraceptive pill that is used to prevent pregnancy after unprotected sex or after failure of another birth control method.

10. ec.europa.eu ec.europa.eu/health/documents/community-register/2014/20141001129545/anx_129545_en.pdf

Ellaone, INN-ulipristal acetate Emergency contraception with ellaOne does not prevent pregnancy in every case. No data is available on the efficacy of ellaOne for women who have had ...