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

NCT03296098 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CCN013B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Contraception; Healthy Female

Keywords

Contraception; Healthy Female; Progestin; ulipristal acetate

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (22)

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

  6 months

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

  6 months

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

  6 months

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

  6 months

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

  6 months

Study Arms (1)

ulipristal acetate

EXPERIMENTAL

Subjects will be administered ulipristal acetate in 5 mg dosages and instructed to take two pills once daily for 6 months.

Drug: Ulipristal acetate

Interventions

Ulipristal acetate DRUG

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

ulipristal acetate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• a. 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.
• 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).

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Premier Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (18)

Essential Access

Los Angeles, California, 90010, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Hawaii

Honolulu, Hawaii, 96826, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

New York University, School of Medicine

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland MacDonald Women's Hospital

Cleveland, Ohio, 44106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Univeristy of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Utah

Salt Lake City, Utah, 84106, United States

Location

Eastern Virginia Medical School (EVMS)

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

ulipristal acetate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 28, 2017
• Study Start: December 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (18)