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Summary

for females ages 18–35 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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)

Details

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 200 subjects to use the UPA for 10 months. In addition to contraceptive efficacy, safety, overall acceptability of the product, and the number of bleeding/spotting days will be assessed.

Keywords

Contraception Healthy Female Progestin ulipristal acetate Contraceptive Agents

Eligibility

You can join if…

Open to females ages 18–35

To enroll into the clinical trial, potential subjects must:

  1. Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
  2. Be women between 18 and 35 years inclusive at the enrollment visit.
  3. Have regular menstrual cycles that occur every 21-35 days when not using hormonal contraception.
  4. If subject is postpartum or post-abortal (after a second trimester abortion), she must have 3 menstrual bleeds prior to enrollment.
  5. If subject had an abortion in the first trimester, she must have one spontaneous menstrual bleed prior to enrollment.
  6. Be seeking contraception, and willing to use the study drug as the only contraception method during their months of study participation.
  7. Be completing her last pack of oral contraceptives or at the completion of the effectiveness period for a contraceptive injection or ring and have a withdrawal bleed prior to enrollment.
  8. Have a spontaneous menses after removal of either a local hormonal intrauterine device(IUD) or non-hormonal IUD prior to enrollment.
  9. Not have used long-acting injectable contraceptives (e.g. depomedroxyprogesterone acetate) during the 6 months prior to screening unless the subject has returned to normal menses (two menstrual bleeds) since last injection.
  10. Have a negative urine pregnancy test at the enrollment visit.
  11. Have an intact uterus and both ovaries.
  12. . 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.
  13. . Understand and sign an (Institutional Review Board) IRB approved informed consent form prior to screening activities (including fasting blood draws).
  14. . 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.
  15. . Have a body mass index (BMI) < 40 kg/m2.
  16. . Be planning to have at least one act of heterosexual vaginal intercourse each month during study participation.
  17. . Be willing to accept an unknown risk of pregnancy during study participation.

You CAN'T join if...

To enroll into the clinical trial, potential subjects must not:

  1. Be women with irregular menstrual cycles defined as a variation in cycle length of more than 5 days.
  2. Be planning pregnancy within their months of study participation.
  3. 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.
  4. Have undiagnosed abnormal genital bleeding.
  5. Have known hypersensitivity to the active substance UPA or any of the excipients of the study treatment.
  6. Have a history of endometrial hyperplasia or malignancy.
  7. Have abnormal Transvaginal Ultrasound (TVUS) or safety labs done at the screening visit recognized as clinically significant by the investigator (or medically qualified designee).
  8. Be a subject with a previous history of endometrial ablation.
  9. Have a known clinically significant Pap test abnormality, as managed by current local or national guidelines, that would require treatment during study participation.
  10. . Have any of the following known contraindication to progestin-only oral contraceptive(OC):
  11. History or existing breast cancer, or other hormone sensitive neoplasia;
  12. Current or history of ischemic heart disease or stroke while pregnant or taking birth control pills;
  13. Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies;
  14. Benign or malignant liver tumors;
  15. Severe (decompensated) cirrhosis.
  16. . Have known or suspected alcoholism or drug abuse.
  17. . Have known HIV infection.
  18. . Have an anticipated need for regular condom use as defined as use of at least one condom per month after enrollment.
  19. . Have previously participated in the study.
  20. . Have a current need for exogenous hormones or therapeutic anticoagulants.
  21. . Have a current or history of deep vein thromboembolic disorder or aortic thromboembolism, including stroke and myocardial infarction
  22. . 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.
  23. . 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).
  24. . 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.
  25. . 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).
  26. . 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.
  27. . Have a history of a bariatric surgery procedure associated with malabsorption.
  28. . Be planning to undergo major surgery during study participation.
  29. . Live outside of the catchment area of the study site.
  30. . Have used UPA, including Ella, within 30 days prior to enrollment.
  31. . Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco, California, 94110, United States
  • University of California, Davis not yet accepting patients
    Sacramento, California, 95817, United States
  • California Family Health Council not yet accepting patients
    Los Angeles, California, 90010, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Health Decisions
ID
NCT03296098
Phase
Phase 2
Lead Scientist
Phillip Darney
Study Type
Interventional
Last Updated
September 27, 2017
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