Clinical trial NCT02689804: EC PK in Women With Normal and Obese BMI
Official title: Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Emergency contraception
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.

Detailed description: Eligible women will present to the division research office, at which time a history and physical exam will be completed. Each participant's BMI will be confirmed and she will be assigned to one of two BMI groups (18.5-24.9 versus 30-39.9). At the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like Plan B One-Step® or its generic formulations) or ulipristal acetate 30mg (ellaOne®) on two separate occasions.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-45 years
* English-speaking
* BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2
* Regular menstrual cycles
* No use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles
* No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle
* Women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy

Exclusion Criteria:

* Prior allergic reaction to LNG-EC or UPA-EC
* Use of hormonal emergency contraception within the past month
* Women who are currently pregnant or who are currently breastfeeding
* History of cancer other than non-melanoma skin cancer
* Medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism

  * Use of HAART therapy for management of HIV infection
  * Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St. John's Wort and topiramate
* Current participation in any other trial of an investigational medicine or device in the three months leading up to this study

Primary outcomes:
measure: Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration
timeFrame: Up to 24 hours
measure: Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Elimination Half-life of Serum LNG
timeFrame: Up to 24 hours
measure: Elimination Half-life of Serum UPA
timeFrame: Up to 24 hours
measure: Clearance of Serum LNG
timeFrame: Up to 24 hours
measure: Clearance of Serum UPA
timeFrame: Up to 24 hours
measure: Maximum Concentration of Serum LNG
timeFrame: Up to 24 hours
measure: Maximum Concentration of Serum UPA
timeFrame: Up to 24 hours
measure: Time to Maximum Concentration of Serum LNG
timeFrame: Up to 24 hours
measure: Time to Maximum Concentration of Serum UPA
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Director, Division of Family Planning and Preventive Services
name: Carolyn L Westhoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical instructor, Division of Family Planning and Preventive Services
name: Piyapa Praditpan, MD
role: STUDY_DIRECTOR
References:
citation: Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.
citation: Kapp N, Abitbol JL, Mathe H, Scherrer B, Guillard H, Gainer E, Ulmann A. Effect of body weight and BMI on the efficacy of levonorgestrel emergency contraception. Contraception. 2015 Feb;91(2):97-104. doi: 10.1016/j.contraception.2014.11.001. Epub 2014 Nov 8.
citation: Gemzell-Danielsson K, Kardos L, von Hertzen H. Impact of bodyweight/body mass index on the effectiveness of emergency contraception with levonorgestrel: a pooled-analysis of three randomized controlled trials. Curr Med Res Opin. 2015 Dec;31(12):2241-8. doi: 10.1185/03007995.2015.1094455. Epub 2015 Oct 27.