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ContraceptionPhase 4NCT02689804

EC PK in Women With Normal and Obese BMI

A Phase 4 study testing LNG-EC and UPA-EC in people with Contraception, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
LNG-EC and UPA-EC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
10 Jul 2015to 3 Feb 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

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

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.

Read the 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
Being tested
LNG-EC, UPA-EC
Keywords
Emergency contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LNG-ECDrug

    Also called Levonorgestrel (LNG) emergency contraceptive (EC), Next Choice One Dose

    FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg

  • UPA-ECDrug

    Also called Ulipristal acetate (UPA) emergency contraceptive (EC), ella

    FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg

Study groups in NCT02689804
Study groupRoleWhat they receive
Normal-BMIOtherWomen 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.
Receives: Drug: LNG-EC; Drug: UPA-EC
Obese-BMIOtherWomen 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.
Receives: Drug: LNG-EC; Drug: UPA-EC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 hours

  2. 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.

    Measured: Up to 24 hours

Secondary outcomes (8)

  1. Elimination Half-life of Serum LNG

    (t1/2) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

  2. Elimination Half-life of Serum UPA

    (t1/2) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

  3. Clearance of Serum LNG

    (Cl) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

  4. Clearance of Serum UPA

    (Cl) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

  5. Maximum Concentration of Serum LNG

    (Cmax) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

  6. Maximum Concentration of Serum UPA

    (Cmax) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

  7. Time to Maximum Concentration of Serum LNG

    (Tmax) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

  8. Time to Maximum Concentration of Serum UPA

    (Tmax) calculated in women with normal and obese BMI

    Measured: Up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2016 (estimated)
  2. Study start10 Jul 2015
  3. Primary completion29 Dec 2015
  4. Study completion3 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689804
Sponsor's protocol ID
AAAP1857
Status last verified
Jun 2017
First submitted
16 Feb 2016
Last updated
7 Jul 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21920190

  • 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.

    PubMed 25528415

  • 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.

    PubMed 26368848

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing LNG-EC and UPA-EC in people with Contraception, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration (time frame: Up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02689804, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.

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