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ContraceptionPhase 2CCN013BNCT03296098

Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive

A Phase 2 study testing Ulipristal acetate in people with Contraception and Healthy Female, run by Premier Research at 18 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Phase IIb multicenter, open-label, non-comparative trial of continuous daily oral 10 mg of ulipristal acetate (UPA) to evaluate its contraceptive efficacy as the primary method of contraception. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception, Healthy Female
What is being tested?
Ulipristal acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
18 sitesUnited States
Study dates
Dec 2020to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • To enroll into the clinical trial, potential subjects must:
  • Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
  • Be women between 18 and 35 years inclusive at the enrollment visit.
  • Have regular menstrual cycles that occur every 21-35 days when not using hormonal contraception.
  • If subject is postpartum or post-abortal, she must have one menstrual bleed prior to enrollment.
  • Be seeking contraception, and willing to use the study drug as the only contraception method during their months of study participation.
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  • If using a ring, patch, pill, or implant prior to study treatment, the subject must discontinue the active hormone at least 4 days, and no more than 7 days, prior to study drug initiation. Note that for combined oral contraceptive users, placebo pills are not counted as active hormone.
  • If using a hormonal intrauterine device (IUD) prior to study treatment, the IUD must be removed prior to study drug initiation; removal and study drug initiation can occur on the same day, but the subject must refrain from sexual intercourse for 7 days following IUD removal.
  • If using a copper IUD prior to study treatment, the IUD must be removed prior to study drug initiation; removal and study drug initiation can occur on the same day. The IUD removal and study drug initiation must occur during the first 7 days of a spontaneous menses.
  • If using a non-hormonal contraceptive method (e.g. condoms or withdrawal) prior to study treatment, drug initiation should occur within the first 7 days of a spontaneous menses.
  • If the woman has received a long-acting injectable contraceptive (e.g. depomedroxyprogesterone acetate) during the 10 months prior to screening, she must have resumed cyclic spontaneous menses (two menstrual bleeds) since last injection.
  • Have a negative urine pregnancy test at the enrollment visit.
  • Have an intact uterus and both ovaries.
  • In the opinion of the investigator, be willing and able to follow all study requirements, including use of the study product and be willing to record requested information on a daily diary.
  • Understand and sign an (Institutional Review Board) IRB approved informed consent form prior to screening activities (including fasting blood draws).
  • Have a diastolic blood pressure (BP) ≤95 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in a sitting position at the enrollment visit. Hypertensive subjects who are treatment controlled and, in the judgment of the investigator, are good candidates require a waiver for participation.
  • Have a body mass index (BMI) < 40 kg/m2.
  • Be planning to have at least one act of heterosexual vaginal intercourse each month during study participation.
  • Be willing to accept an unknown risk of pregnancy during study participation.

Who cannot join

  • To enroll into the clinical trial, potential subjects must not:
  • Be women with irregular menstrual cycles defined as a variation in cycle length of more than 5 days.
  • Be planning pregnancy within their months of study participation.
  • Be currently breast-feeding or within 30 days of discontinuing breast feeding, unless the subject has already had a menses following discontinuation of breast feeding.
  • Have undiagnosed abnormal genital bleeding.
  • Have known hypersensitivity to the active substance UPA or any of the excipients of the study treatment.
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  • Have a history of endometrial hyperplasia or malignancy.
  • Have abnormal Transvaginal Ultrasound (TVUS) or safety labs done at the screening visit recognized as clinically significant by the investigator (or medically qualified designee).
  • Have a previous history of endometrial ablation.
  • Have a previous history of liver disease or screening liver enzyme results more than three times the upper limit of normal values.
  • Have a known clinically significant Pap test abnormality, as managed by current local or national guidelines, that would require treatment during study participation.
  • Have any of the following known contraindication to progestin-only oral contraceptive (OC):
  • History or existing breast cancer, or other hormone sensitive neoplasia;
  • Current or history of ischemic heart disease or stroke while pregnant or taking birth control pills;
  • Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies;
  • Benign or malignant liver tumors;
  • Severe (decompensated) cirrhosis.
  • Have known or suspected alcoholism or drug abuse.
  • Have known HIV infection.
  • Have an anticipated need for regular condom use as defined as use of at least one condom per month after enrollment.
  • Have previously participated in the study.
  • Have a current need for exogenous hormones or therapeutic anticoagulants.
  • Have a current or history of deep vein thromboembolic disorder or aortic thromboembolism, including stroke and myocardial infarction
  • Have a current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication.
  • Have concomitant use of medication thought to interact with UPA (per Summary of Product Characteristics (SPCs)) such as CYP3A4 inducers (rifampin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St John's Wort, topiramate).
  • Have concomitant use of moderate or strong CYP3A4 inhibitors as identified by the FDA. Subjects who begin use of a moderate CYP3A4 inhibitor after study enrollment require a waiver to continue in the study.
  • Use any medications that can interfere with the metabolism of hormonal contraceptives, antibiotics that can interfere with metabolism of hormonal contraceptives, or any drugs designated by the FDA as falling in the Pregnancy and Lactation narrative subsections (formerly Category D or X medications).
  • Currently participate in any other trial of an investigational medicine or device or have participated in the three months before start of treatment or be planning to participate in another clinical trial during this study.
  • Have a history of a bariatric surgery procedure associated with malabsorption.
  • Be planning to undergo major surgery during study participation.
  • Live outside of the catchment area of the study site.
  • Have used UPA, including Ella, within 30 days prior to enrollment and not had a menses since using UPA.
  • Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Planned Parenthood League of Massachusetts

    Boston, Massachusetts, 02215

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals of Cleveland MacDonald Women's Hospital

    Cleveland, Ohio, 44106

  • University of Colorado

    Denver, Colorado, 80045

  • University of Hawaii

    Honolulu, Hawaii, 96826

  • Essential Access

    Los Angeles, California, 90010

  • New York University, School of Medicine

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Eastern Virginia Medical School (EVMS)

    Norfolk, Virginia, 23507

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Univeristy of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • University of California, Davis

    Sacramento, California, 95817

  • University of Utah

    Salt Lake City, Utah, 84106

  • University of California, San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: A Multi-center, Open-label, Non-comparative Study of the Safety and Contraceptive Efficacy of Continuous Daily Oral 10 mg of Ulipristal Acetate (UPA)

This is a Phase IIb multicenter, open-label, non-comparative trial of continuous daily oral 10 mg of ulipristal acetate (UPA) to evaluate its contraceptive efficacy as the primary method of contraception.

Read the detailed description

This is an open-label study being conducted at 18 centers. The dose of 10 mg was chosen for daily continuous use of ulipristal acetate (UPA). The study will enroll approximately 300 subjects to use the UPA for 6 months (182 days). In addition to contraceptive efficacy, safety, overall acceptability of the product, and the number of bleeding/spotting days will be assessed.

Being tested
Ulipristal acetate
Keywords
Contraception, Healthy Female, Progestin, ulipristal acetate

What participants receive

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

  • Ulipristal acetateDrug

    Ulipristal aceteate 5 mg oral tablets to take two tablets daily.

Study groups in NCT03296098
Study groupRoleWhat they receive
ulipristal acetateExperimentalSubjects will be administered ulipristal acetate in 5 mg dosages and instructed to take two pills once daily for 6 months.
Receives: Drug: Ulipristal acetate

What is being measured

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

  1. Evaluate the contraceptive efficacy at 6 months based on the calculated Pearl Index for the evaluable for pregnancy population.

    Measured: 6 months

Secondary outcomes (22)

  1. Incidence of treatment emergent adverse events (safety and tolerability) during 6 month use of UPA.

    Measured: 6 months

  2. Changes from baseline in sodium levels (safety and tolerability).

    Measured: 6 months

  3. Changes from baseline in potassium levels (safety and tolerability).

    Measured: 6 months

  4. Changes from baseline in chloride levels (safety and tolerability).

    Measured: 6 months

  5. Changes from baseline in bicarbonate levels (safety and tolerability).

    Measured: 6 months

  6. Changes from baseline in fasting glucose levels (safety and tolerability).

    Measured: 6 months

  7. Changes from baseline in blood urea nitrogen levels (safety and tolerability).

    Measured: 6 months

  8. Changes from baseline in creatinine levels (safety and tolerability).

    Measured: 6 months

  9. Changes from baseline in calcium levels (safety and tolerability).

    Measured: 6 months

  10. Changes from baseline in total bilirubin levels (safety and tolerability).

    Measured: 6 months

  11. Changes from baseline in total alkaline phosphatase levels (safety and tolerability).

    Measured: 6 months

  12. Changes from baseline in total alanine aminotransferase levels (safety and tolerability).

    Measured: 6 months

  13. Changes from baseline in total aspartate transaminase levels (safety and tolerability).

    Measured: 6 months

  14. Changes from baseline in total albumin levels (safety and tolerability).

    Measured: 6 months

  15. Changes from baseline in total cholesterol levels (safety and tolerability).

    Measured: 6 months

  16. Changes from baseline in HDL cholesterol levels (safety and tolerability).

    Measured: 6 months

  17. Changes from baseline in LDL cholesterol levels (safety and tolerability).

    Measured: 6 months

  18. Changes from baseline in triglycerides levels (safety and tolerability).

    Measured: 10 months

  19. Changes from baseline in acceptability of UPA using an Acceptability Questionnaire (acceptability).

    Measured: 6 months

  20. Changes from baseline in bleeding pattern using a subject diary (tolerability).

    Measured: 6 months

  21. Changes from baseline in endometrial thickness using transvaginal ultrasound.

    Measured: 6 months

  22. Changes from baseline in endometrium using endometrial biopsy results.

    Measured: 6 months

Timeline

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

  1. First posted28 Sep 2017
  2. Study startDec 2020 (estimated)
  3. Primary completionJan 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Why it stopped: withdrawn due to FDA feedback

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03296098
Sponsor's protocol ID
CCN013B
Acronym
CCN013B
Status last verified
Nov 2025
First submitted
22 Sep 2017
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ulipristal acetate in people with Contraception and Healthy Female, run by Premier Research at 18 sites in United States.

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 19 inclusion and 33 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: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Evaluate the contraceptive efficacy at 6 months based on the calculated Pearl Index for the evaluable for pregnancy population. (time frame: 6 months). 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 NCT03296098.

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 20 Nov 2025.

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