EC PK in Women With Normal and Obese BMI

Contraception Clinical Trial

Official title:

Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689804
• Other study ID #: AAAP1857
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2016
• Last updated: June 30, 2017
• Start date: July 10, 2015
• Est. completion date: February 3, 2017

Study information

• Verified date: June 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 3, 2017
• Est. primary completion date: December 29, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• LNG-EC
FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg
• UPA-EC
FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Kapp N, Abitbol JL, Mathé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration	LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.	Up to 24 hours
Primary	Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration	UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.	Up to 24 hours
Secondary	Elimination Half-life of Serum LNG	(t1/2) calculated in women with normal and obese BMI	Up to 24 hours
Secondary	Elimination Half-life of Serum UPA	(t1/2) calculated in women with normal and obese BMI	Up to 24 hours
Secondary	Clearance of Serum LNG	(Cl) calculated in women with normal and obese BMI	Up to 24 hours
Secondary	Clearance of Serum UPA	(Cl) calculated in women with normal and obese BMI	Up to 24 hours
Secondary	Maximum Concentration of Serum LNG	(Cmax) calculated in women with normal and obese BMI	Up to 24 hours
Secondary	Maximum Concentration of Serum UPA	(Cmax) calculated in women with normal and obese BMI	Up to 24 hours
Secondary	Time to Maximum Concentration of Serum LNG	(Tmax) calculated in women with normal and obese BMI	Up to 24 hours
Secondary	Time to Maximum Concentration of Serum UPA	(Tmax) calculated in women with normal and obese BMI	Up to 24 hours