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

Conditions:Contraception, Contraception, Hospital
Therapuetic Areas:Other, Reproductive
Age Range:18 - 40
Start Date:July 12, 2018
End Date:August 1, 2019
Contact:Amber Blackmon

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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

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.

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.

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

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. -
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