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Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

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ClinicalTrials.gov Identifier: NCT03537768
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Health Decisions

Brief Summary:
The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80 kg who present within 72 hours of unprotected intercourse.

Condition or disease Intervention/treatment Phase
Contraception Drug: Ulipristal Acetate Drug: Levonorgestrel Phase 4

Detailed Description:

Orally-dosed emergency contraception (EC) is highly effective when used properly. EC is up to 90% effective at preventing pregnancy following unprotected intercourse. Both ulipristal acetate (UPA) and levonorgestrel (LNG) delay or inhibit ovulation when used for EC. For individual women, use of EC provides a critical backup to prevent unintended pregnancy.

However, obesity may severely impair EC effectiveness. Data from two large randomized control trials to identify risk factors for EC failure. A woman of obese body mass index (BMI) (≥30mg/kg2) using LNG-based EC had more than a 4 times greater risk of pregnancy compared to her normal BMI counterpart and a woman of overweight BMI (25-29.9) was at twice the risk of pregnancy. Failure was also associated with a high body weight. LNG-based EC appears to have a ceiling of efficacy at 70 kg and no efficacy for women 80 kg and above. It is believed that by doubling the dose to LNG 3.0 mg, serum levels of LNG are corrected to a therapeutic range.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Multi-center, Randomized Study of the Efficacy of Ulipristal Acetate (UPA) 30 mg, Levonorgestrel (LNG) 1.5 mg, and LNG 3.0 mg for Emergency Contraception (EC) in Women With Weight ≥ 80 kg
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: UPA 30mg Drug: Ulipristal Acetate
UPA Tablet
Other Name: Ella

Active Comparator: LNG 1.5 mg Drug: Levonorgestrel
LNG Tablet
Other Name: Plan B

Active Comparator: LNG 3.0 Drug: Levonorgestrel
LNG Tablet (x2)
Other Name: Plan B (double dose)




Primary Outcome Measures :
  1. Incidence of pregnancies of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥ 80 kg for emergency contraception (within 72 hours of unprotected intercourse). [ Time Frame: 1-3 months ]

Secondary Outcome Measures :
  1. Incidence of treatment emergent adverse events of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥80 kg seeking emergency contraception. [ Time Frame: 1-3 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
  2. Between 18 and 40 years inclusive at the enrollment visit.
  3. Weight ≥ 80 kg.
  4. Have regular menstrual cycles that typically occur every 21-35 days when not using hormonal contraception.
  5. If subject is postpartum or post-abortal, she must have experienced a menstrual bleed since the pregnancy ended
  6. If a subject recently used non-injectable hormonal contraception, one bleeding episode consistent with menses must have occurred since last use;
  7. Willing to avoid use of any hormonal or intrauterine contraception until the end of the study;
  8. For women with a recent history of Depo Provera use, the most recent injection must have been at least 6 months before study entry, and the subject must have had at least one normal menstrual cycle (2 consecutive menses);
  9. Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, condom breakage (including condoms lubricated with spermicide), or other barrier contraceptive method failure;
  10. Have a negative urine pregnancy test at time of screening
  11. Reports all acts of unprotected coitus since her prior menses are within 72 hours prior to enrollment;
  12. Willing to abstain from further acts of unprotected intercourse until the end of the study;
  13. Give voluntary, written informed consent, and agree to observe all study requirements including being available for follow up for at least the next 4 weeks;
  14. Accepts that the risk of pregnancy with oral EC is greater than that following placement of a copper IUD for EC.

Exclusion Criteria:

  1. Be currently pregnant (positive high-sensitivity urine pregnancy test);
  2. Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding;
  3. Desire to use hormonal systemic contraception within 5 days of study drug use
  4. Have had a female sterilization procedure;
  5. Have a partner with a history of vasectomy;
  6. Current inability to tolerate oral medication;
  7. Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.
  8. Have known liver disease;
  9. Have known liver abnormalities with elevated enzymes at least twice the upper limit of normal requiring use of liver enzyme inducers.
  10. Have known hypersensitivity to the active substance UPA or LNG, or any of the excipients of the study treatment.
  11. Have a current need for exogenous hormones.
  12. Have concomitant use of strong CYP3A4 inhibitors (as identified by the FDA) or inducers at the time of or planned use within 3 days of dosing;
  13. Use any medications that can interfere with the metabolism of hormonal contraceptives; take antibiotics that can interfere with metabolism of hormonal contraceptives at the time of or planned use within 3 days of dosing of the study drug; or use any drugs designated by the FDA as falling in the Pregnancy and Lactation narrative subsections (formerly Category D or X medications).
  14. Current or recent (within one month) participation in any other trial of an investigational medicine or device or planning to participate in another clinical trial during this study.
  15. Have a history of a bariatric surgery procedure associated with malabsorption.
  16. Live outside of the catchment area of the study site.
  17. Have used UPA or LNG EC within 30 days prior to enrollment and not had a menses since using the drug.
  18. Be a site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537768


Contacts
Contact: Amber Blackmon 919-967-1111 ext 117 sblackmon@healthdec.com

Locations
United States, California
Essential Access Health Recruiting
Los Angeles, California, United States, 30010
Contact: Kieumai Vo    213-386-5614 ext 4592    KVo@essentialaccess.org   
Contact: Ron Frezeries    213-386-5614 ext 4403    RFrezieres@essentialaccess.org   
Principal Investigator: Anita Nelson         
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Courtney Overstreet    916-734-6846    cboverstreet@ucdavis.edu   
Contact: Aubrey Blanton    916-734-6846    akblanton@ucdavis.edu   
Principal Investigator: Mitchell Creinin         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Abby Sokoloff       sokoloffa@obgyn.ucsf.edu   
Principal Investigator: Philip Darney, MD         
United States, Colorado
University of Colorado Not yet recruiting
Denver, Colorado, United States, 80045
Contact: Ines Crato       ines.crato@ucdenver.edu   
Principal Investigator: Stephanie Teal, MD         
United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Tiana Fontanilla    808-203-6594    tfontanilla@ucera.org   
Principal Investigator: Bliss Kaneshiro, MD         
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Sadia Haider         
Contact: Kate Lewis    773-834-5437    klewis2@uchicago.edu   
United States, Maryland
Johns Hopkins Bayview Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Katrina Thaler    410-550-8506    kstouff3@jhmi.edu   
Contact: Lauren Beal    410-550-4825    lbeal2@jhu.edu   
Principal Investigator: Anne Burke         
United States, Massachusetts
Planned Parenthood League of Massachusetts Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jennifer Fortin       jfortin@pplm.org   
Principal Investigator: Alisa Goldberg, MD         
United States, New York
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Contact: Anna Davis    212-263-6253    anna.davis@nyumc.org   
Principal Investigator: Treasure Walker         
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Subrina Bisnauth    212-305-8031    Snb2147@cumc.columbia.edu   
Contact: Connie Colon    212-305-6098    cc3238@cumc.columbia.edu   
Principal Investigator: Carolyn Westhoff         
United States, Ohio
University of Cincinnati-Holmes Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Tiffany Rupert    513-584-4130    tiffany.rupert@uc.edu   
Principal Investigator: Michael Thomas, MD         
University Hospitals of Cleveland MacDonald Women's Hospital Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: James H. Liu, MD    440-720-3250    james.liu@uhhs.com   
Contact: Lisa Wolfe    440-995-3811    Lisa.Wolfe@UHHospitals.org   
Principal Investigator: James H. Liu, MD         
United States, Oregon
Oregon Health Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Ariela Schnyer    503-494-3173    schnyer@ohsu.edu   
Principal Investigator: Alison Edelman         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Arden McAllister       Arden.Mcallister@uphs.upenn.edu   
Principal Investigator: Courtney Schreiber, MD         
University of Pittsburgh/Magee Women's Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Beatrice Chen, MD         
United States, Rhode Island
Women & Infants Hospital of Rhode Island Not yet recruiting
Providence, Rhode Island, United States, 02905
Contact: Rebecca Allen         
Contact: Mindy Marshall       mamarshall@wihri.org   
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84106
Contact: Amy Orr    801-213-2774    amy.orr@hsc.utah.edu   
Principal Investigator: David Turok, MD         
United States, Virginia
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jackie Rocccazella    757-446-7161    roccazj@evms.edu   
Contact: Kim Pitts    757-446-8925    pittska@evms.edu   
Principal Investigator: David Archer         
Sponsors and Collaborators
Health Decisions
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Diana Blithe, PhD NICHD Director

Responsible Party: Health Decisions
ClinicalTrials.gov Identifier: NCT03537768     History of Changes
Other Study ID Numbers: CCN013C
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral