EC PK in Women With Normal and Obese BMI

NCT ID: NCT02689804

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-10
• Study Completion Date: 2017-02-03

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normal-BMI

Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.

Group Type: OTHER

LNG-EC

Intervention Type: DRUG

FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

UPA-EC

Intervention Type: DRUG

FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Obese-BMI

Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.

Group Type: OTHER

LNG-EC

Intervention Type: DRUG

FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

UPA-EC

Intervention Type: DRUG

FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Interventions

LNG-EC

FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

Intervention Type: DRUG

UPA-EC

FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Intervention Type: DRUG

Other Intervention Names

Levonorgestrel (LNG) emergency contraceptive (EC); Next Choice One Dose; Ulipristal acetate (UPA) emergency contraceptive (EC); ella

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Carolyn L. Westhoff

Director, Division of Family Planning and Preventive Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn L Westhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Division of Family Planning and Preventive Services

Piyapa Praditpan, MD

Role: STUDY_DIRECTOR

Clinical instructor, Division of Family Planning and Preventive Services

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21920190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25528415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26368848 (View on PubMed)

Study Documents

Document Type: Publication

Results Reference: Yes

View Document

Other Identifiers

AAAP1857

Identifier Type: -

Identifier Source: org_study_id