search
Back to results

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

Primary Purpose

Contraception

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ulipristal Acetate
Levonorgestrel
Levonorgestrel
Sponsored by
Health Decisions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contraception

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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. -

Sites / Locations

  • Essential Access HealthRecruiting
  • University of California, DavisRecruiting
  • University of California, San FranciscoRecruiting
  • University of Colorado
  • University of HawaiiRecruiting
  • University of Chicago
  • Johns Hopkins Bayview Medical Center
  • Planned Parenthood League of MassachusettsRecruiting
  • Bellevue Hospital CenterRecruiting
  • Columbia University
  • University of Cincinnati-Holmes HospitalRecruiting
  • University Hospitals of Cleveland MacDonald Women's Hospital
  • Oregon Health Science UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • University of Pittsburgh/Magee Women's Hospital
  • Women & Infants Hospital of Rhode Island
  • University of Utah
  • Eastern Virginia Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

UPA 30mg

LNG 1.5 mg

LNG 3.0

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
April 17, 2018
Last Updated
October 7, 2019
Sponsor
Health Decisions
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03537768
Brief Title
Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Decisions
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UPA 30mg
Arm Type
Active Comparator
Arm Title
LNG 1.5 mg
Arm Type
Active Comparator
Arm Title
LNG 3.0
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ulipristal Acetate
Other Intervention Name(s)
Ella
Intervention Description
UPA Tablet
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel
Other Intervention Name(s)
Plan B
Intervention Description
LNG Tablet
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel
Other Intervention Name(s)
Plan B (double dose)
Intervention Description
LNG Tablet (x2)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care. Between 18 and 40 years inclusive at the enrollment visit. Weight ≥ 80 kg. Have regular menstrual cycles that typically occur every 21-35 days when not using hormonal contraception. If subject is postpartum or post-abortal, she must have experienced a menstrual bleed since the pregnancy ended If a subject recently used non-injectable hormonal contraception, one bleeding episode consistent with menses must have occurred since last use; Willing to avoid use of any hormonal or intrauterine contraception until the end of the study; 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); 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; Have a negative urine pregnancy test at time of screening Reports all acts of unprotected coitus since her prior menses are within 72 hours prior to enrollment; Willing to abstain from further acts of unprotected intercourse until the end of the study; 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; Accepts that the risk of pregnancy with oral EC is greater than that following placement of a copper IUD for EC. Exclusion Criteria: Be currently pregnant (positive high-sensitivity urine pregnancy test); Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding; Desire to use hormonal systemic contraception within 5 days of study drug use Have had a female sterilization procedure; Have a partner with a history of vasectomy; Current inability to tolerate oral medication; Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year. Have known liver disease; Have known liver abnormalities with elevated enzymes at least twice the upper limit of normal requiring use of liver enzyme inducers. Have known hypersensitivity to the active substance UPA or LNG, or any of the excipients of the study treatment. Have a current need for exogenous hormones. 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; 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). 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. Have a history of a bariatric surgery procedure associated with malabsorption. Live outside of the catchment area of the study site. Have used UPA or LNG EC within 30 days prior to enrollment and not had a menses since using the drug. Be a site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Blackmon
Phone
919-967-1111
Ext
117
Email
sblackmon@healthdec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Blithe, PhD
Organizational Affiliation
NICHD Director
Official's Role
Study Director
Facility Information:
Facility Name
Essential Access Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
30010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kieumai Vo
Phone
213-386-5614
Ext
4592
Email
KVo@essentialaccess.org
First Name & Middle Initial & Last Name & Degree
Ron Frezeries
Phone
213-386-5614
Ext
4403
Email
RFrezieres@essentialaccess.org
First Name & Middle Initial & Last Name & Degree
Anita Nelson
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Overstreet
Phone
916-734-6846
Email
cboverstreet@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Aubrey Blanton
Phone
916-734-6846
Email
akblanton@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Mitchell Creinin
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Sokoloff
Email
sokoloffa@obgyn.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Philip Darney, MD
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Crato
Email
ines.crato@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Teal, MD
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiana Fontanilla
Phone
808-203-6594
Email
tfontanilla@ucera.org
First Name & Middle Initial & Last Name & Degree
Bliss Kaneshiro, MD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadia Haider
First Name & Middle Initial & Last Name & Degree
Kate Lewis
Phone
773-834-5437
Email
klewis2@uchicago.edu
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Thaler
Phone
410-550-8506
Email
kstouff3@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Lauren Beal
Phone
410-550-4825
Email
lbeal2@jhu.edu
First Name & Middle Initial & Last Name & Degree
Anne Burke
Facility Name
Planned Parenthood League of Massachusetts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Fortin
Email
jfortin@pplm.org
First Name & Middle Initial & Last Name & Degree
Alisa Goldberg, MD
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Davis
Phone
212-263-6253
Email
anna.davis@nyumc.org
First Name & Middle Initial & Last Name & Degree
Treasure Walker
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subrina Bisnauth
Phone
212-305-8031
Email
Snb2147@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Connie Colon
Phone
212-305-6098
Email
cc3238@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Westhoff
Facility Name
University of Cincinnati-Holmes Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Rupert
Phone
513-584-4130
Email
tiffany.rupert@uc.edu
First Name & Middle Initial & Last Name & Degree
Michael Thomas, MD
Facility Name
University Hospitals of Cleveland MacDonald Women's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James H. Liu, MD
Phone
440-720-3250
Email
james.liu@uhhs.com
First Name & Middle Initial & Last Name & Degree
Lisa Wolfe
Phone
440-995-3811
Email
Lisa.Wolfe@UHHospitals.org
First Name & Middle Initial & Last Name & Degree
James H. Liu, MD
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariela Schnyer
Phone
503-494-3173
Email
schnyer@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Alison Edelman
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arden McAllister
Email
Arden.Mcallister@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Courtney Schreiber, MD
Facility Name
University of Pittsburgh/Magee Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrice Chen, MD
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Allen
First Name & Middle Initial & Last Name & Degree
Mindy Marshall
Email
mamarshall@wihri.org
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Orr
Phone
801-213-2774
Email
amy.orr@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
David Turok, MD
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Rocccazella
Phone
757-446-7161
Email
roccazj@evms.edu
First Name & Middle Initial & Last Name & Degree
Kim Pitts
Phone
757-446-8925
Email
pittska@evms.edu
First Name & Middle Initial & Last Name & Degree
David Archer

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs