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

Completed · Phase 2

Conditions studied: Focus: Estrogen-free Oral Contraception

In brief

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.

Key facts

Study ID

NCT01953679

Run by

Premier Research

People needed

180

Starts

2014-03-01

Expected to finish

2015-11-01

Last updated by the study team

2016-02-22

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

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):
• In accordance with the Bethesda system of classification: smear suggestive of high-grade pre-cancerous lesion(s), including high grade squamous intraepithelial lesions (HGSILs), are excluded; • Women with low grade squamous intraepithelial lesion (LGSIL) or atypical squamous cells of undetermined significance (ASCUS)/high-risk human papillomavirus (HPV) positive, or Atypical squamous cells, cannot rule out a high grade lesion (ASC-H) may participate if further evaluated with colposcopy and biopsy determines no evidence of a lesion with a severity greater than cervical intraepithelial neoplasia (CIN) I. • Women with a biopsy finding of CIN I should have follow-up for this finding per standard of care; women are excluded if treatment is indicated.
• In accordance with other Pap class systems:
• Women with high grade dysplasia are excluded.
• Women with atypical glandular cells of undetermined significance (AGUS) are excluded.
• Women with low grade dysplasia or CIN I interpretation on Pap test may participate following exclusion of a high grade lesion by colposcopic evaluation based on Investigator discretion and provided there is appropriate follow up in accordance with local standards.
• Has any of the following known contraindication to progestin-only oral contraceptive (OC):
• History or existing breast cancer, or other hormone sensitive neoplasia;
• Current and history of ischemic heart disease or stroke while pregnant or taking birth control pills;
• Acute deep venous thrombosis or pulmonary embolism;
• Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies;

Where it is running

• California Family Health Council — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado - Denver Anschutz Medical Campus — Aurora, Colorado, United States
• University of Chicago — Chicago, Illinois, United States
• NYU School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Cincinnati-Holmes Hospital — Cincinnati, Ohio, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Eastern Virgina Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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