Emergency Contraception and Body Weight: Pilot Study

September 22, 2017 updated by: Alison Edelman, Oregon Health and Science University
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.

We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subjects are between the ages of 18 and 35
  • Subjects are in good general health
  • Subjects have regular menstrual cycles (between 21 and 35 days)
  • Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).

Exclusion Criteria:

  • Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
  • Impaired liver or renal function
  • Actively seeking or involved in a weight loss program (must be weight stable)
  • Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception
  • Current use of drugs that interfere with metabolism of sex steroids
  • Smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Normal BMI ECx1
5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
Drug: ECx1
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.
Other Names:
  • Next choice
  • Emergency Contraception
Active Comparator: Obese BMI ECx1
5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
Drug: ECx1
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.
Other Names:
  • Next choice
  • Emergency Contraception
Active Comparator: Obese BMI ECx2
5 obese women (BMI >30 kg/m2) taking 3mg LNG
Drug: ECx2
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
Other Names:
  • Next choice
  • Emergency Contraception

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
Time Frame: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
Time Frame: Follicular phase of menstrual cycle
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel
Follicular phase of menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Research Foundation, Oregon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison Edelman, MD, MPH, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OHSU IRB 11419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

PI acknowledges willingness to share data and materials with other investigators through established means. Data will be presented via presentation and publication. Transfer of resources is subject to the acceptance of a Materials Transfer Agreement as required by policy at OHSU. OHSU complies with NIH policy on Sharing Research Data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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