Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days

NCT01953679 | Completed Phase 2 DMC

• 1 other identifier: CCN013
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 10

Brief Summary

To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.

Conditions

Focus: Estrogen-free Oral Contraception

Outcome Measures

Primary Outcomes (1)

• Ovulation inhibition

  * Two consecutive serum progesterone values ≥10nMol/L (3ng/mL) within a four day window; * A follicle ≥13 mm followed by a single serum progesterone value ≥10nMol/L (3ng/mL) without a second high progesterone level but with follicle disappearance, suggestive of follicular rupture.

  Approximately 6.5 months

Secondary Outcomes (4)

• Bleeding profile

  Approximately 6.5 months

• Follicle growth and rupture

  Approximately 6.5 months

• Endometrial safety

  Approximately 6.5 months

• Overall subject satisfaction and safety

  Approximately 6.5 months

Study Arms (2)

5mg UPA

ACTIVE COMPARATOR

Continuous regimen of oral daily 5 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval.

Drug: Ulipristal Acetate

10mg UPA

ACTIVE COMPARATOR

Continuous regimen of oral daily 10 mg of ulipristal acetate (UPA) versus a cyclic regimen of 5 mg UPA for 24 days followed by a 4 day hormone free interval.

Drug: Ulipristal Acetate

Interventions

Ulipristal Acetate DRUG

10mg UPA; 5mg UPA

Eligibility Criteria

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

You may qualify if:

• Women between 18 and 35 years old.
• In good health, with regular menstrual cycles that occur every 21-35 days.
• If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles (3 menses) prior to screening.
• If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening.
• No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment.
• a. No use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 6 months prior to screening unless the subject has returned to normal menses since last injection.
• Have a negative urine pregnancy test at the admission visit.
• Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, barrier method with every act of intercourse until the time of study exit OR have a surgically sterile male partner with a vasectomy, must have undergone previous tubal ligation, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
• In the opinion of the investigator, willing and able to follow all study requirements, including use of the study product and willing to record requested information on a daily diary.
• Understand and sign an IRB approved inform consent form prior to screening activities (including fasting blood draws).
• Will have diastolic blood pressure (BP) ≤95 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in sitting position.
• BMI \< 40 kg/m2 and not having previously undergone bariatric surgery.
• Agree not to participate in any other clinical trials during the course of this study.

You may not qualify if:

• Women less than 18 and older than 35 years old.
• Women with menstrual cycle length of less than 21 or more than 35 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days.
• a. If subject is postpartum or post-abortal (with abortion in second trimester) and not had two normal menstrual cycles (3 menses) prior to screening.
• b. If subject had an abortion in the first trimester and not had at least one menstrual cycle (two menses) prior to screening.
• Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test.
• Unwilling to use a barrier method with every act of intercourse until study exit OR not have a surgically sterile male partner with a vasectomy, not have undergone previous tubal ligation, not abstinent, or not in a same-sex relationship from the control period through study exit (including recovery period).
• Women planning pregnancy within their months of study participation.
• Currently breast-feeding or within 30 days of discontinuing breast feeding, unless the woman has already had a menses following discontinuation of breast feeding.
• Current use of an IUD, or other hormonal contraception within last complete menstrual cycle prior to screening.
• a. Use of injectable contraceptives (e.g. cyclofem or depo-medroxyprogesterone acetate) during the 6 months prior to screening without the subject returning to normal menses since last injection.
• Undiagnosed abnormal genital bleeding.
• Known hypersensitivity to the active substance UPA or any of the excipients of the study treatment.
• Anomalies in endometrial appearance, TVUS or safety labs done at screening visit recognized as clinically significant by the investigator.
• Subject with a previous history of endometrial ablation.
• A clinically significant Pap test abnormality, as managed by current local or national guidelines. Women with a current abnormal Pap (within the last eighteen months):

Sponsors & Collaborators

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

Study Sites (10)

California Family Health Council

Los Angeles, California, 90010, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Colorado - Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Cincinnati-Holmes Hospital

Cincinnati, Ohio, 45267, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Eastern Virgina Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

ulipristal acetate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: October 1, 2013
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

US (10)