Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Pivotal Bioequivalence Study of 250 Mcg NGM/25 Mcg EE With or Without Folic Acid in Healthy Female Subjects

The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/25 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.

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

This is a single-center, open-label, randomized (study drug assigned by chance), 3-way crossover bioequivalence study of a single dose of 250 mcg NGM/25 mcg EE with or without folic acid. The study consisted of a pretreatment phase (a screening period lasting up to 21 days), an open-label treatment phase (consisting of 3 periods during which a single dose of study drug was administered followed by up to 72 hours of serial blood sample collections for pharmacokinetic analysis), and a posttreatment phase (consisting of safety evaluations at the completion of the third open-label treatment period or at early withdrawal). All healthy volunteers received the following treatments (1 during each period): Treatment A: 250 mcg NGM/25 mcg EE; Treatment B: 250 mcg NGM/25 mcg EE plus folic acid 400 mcg (combined formulation); Treatment C: folic acid 400 mcg. Healthy volunteers were randomly assigned to 1 of 6 treatment sequence groups (ABC, ACB, BAC, BCA, CAB, or CBA) on Day 1 of the first open-label treatment period. Healthy volunteers received a single dose of study drug on Day 1 in each period according to their assigned treatment sequence. There was a washout period between treatments of at least 4 weeks. Healthy volunteers were confined to the study unit from the evening before dosing (Day -1) until after vital signs were measured following collection of the 24-hour (Treatment C) or 48-hour (Treatments A or B) postdose blood sample. Blood samples were collected at specified times for 24 hours after dosing for the determination of plasma levels of folate and for 72 hours after dosing for the determination of blood levels of norelgestromin (NGMN), and norgestrel (NG) [the active breakdown products of NGM], and EE. Safety was evaluated based on the following: the incidence, type, and severity of adverse events; clinical laboratory tests; vital sign and electrocardiogram (ECG) measurements; and physical and gynecological (including breast) examinations. Oral temperature, heart rate, respiratory rate, and blood pressure were measured at screening, before each dose, and at least 15 minutes after the 24-hour (all treatments) and 48- and 72-hour (healthy volunteers who received Treatments A or B) pharmacokinetic blood samples in each period, or at early withdrawal. In Period 3, the end-of-study assessments were considered the 24-hour (for healthy volunteers who received Treatment C) and the 72-hour (for healthy volunteers who received Treatments A and B) measurements. Physical and gynecologic examinations and ECG were performed at screening, and at least 1 hour after the last pharmacokinetic blood sample on Day 58 for healthy volunteers who received Treatment C in Period 3, on Day 60 for healthy volunteers who received Treatments A or B in Period 3, or at early withdrawal. Blood samples for blood chemistry, hematology, and urine samples for urinalysis were collected at screening, after the last pharmacokinetic blood sample on Day 58 for healthy volunteers who received Treatment C in the third treatment period, on Day 60 for healthy volunteers who received Treatments A or B in Period 3, or at early withdrawal. The total duration of the study, not including the pretreatment phase, was approximately 9 weeks. Treatment A (250 mcg NGM/25 mcg EE) was administered as a single tablet corresponding to Days 15 to 21 in the commercial dialpak of the OC study drug; Treatment B (250 mcg NGM/25 mcg EE plus 400 mcg of folic acid) was administered as a single tablet; and Treatment C (400 mcg of folic acid) was administered as single United States Pharmacopoeia (USP) tablet.

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.
54

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 1

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy
  • nonpregnant
  • nonlactating
  • nonsmoking women
  • weighing at least 110 pounds
  • With regular menstrual cycles
  • A body mass index between 16 and 29.9 kg/m2
  • And a hematocrit of at least 36%.

Exclusion Criteria:

  • History or presence of disorders commonly accepted as contraindications to sex hormonal therapy including: thromboembolic disorders cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines, benign or malignant liver tumor that developed during the use of OC
  • Known or suspected estrogen-dependent neoplasia
  • Presence of disorders commonly accepted as contraindications to combined OC including: undiagnosed abnormal vaginal bleeding, any neurovascular lesion of the eye or serious visual disturbance, or liver disease
  • Intake any multivitamin or folic acid-containing supplements within 21 days before study admission
  • Used a steroid hormone-containing intrauterine device within 3 months before study admission
  • Used any medications that were known cytochrome P-450 enzyme inducers or inhibitors (e.g., St. John's Wort, cimetidine or rifampin), within 60 days before dosing.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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
Determine the bioequivalence of NGM (as measured by the pharmacokinetics of its active breakdown product NGMN) and EE in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.

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
Determine the pharmacokinetics of NG in these 2 formulations; and to characterize the pharmacokinetics of plasma folate after the administration of folic acid alone or in combination with 250 mcg NGM/25 mcg EE. Safety also was assessed.

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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

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Helpful Links

Study record dates

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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.
April 1, 2005

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, 2005

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).
July 1, 2008

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.
July 2, 2008

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.
July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

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.
June 8, 2011

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.
June 6, 2011

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.
March 1, 2010

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.
  • CR002203

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