A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities

October 2, 2014 updated by: Janssen Research & Development, LLC

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities

The purpose of this study is to establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets, formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by dry process, in healthy women.

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 Phase 1, single-dose, open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), randomized (the study medication is assigned by chance), single-center and a 2-way crossover (method used to switch participants from one study group to another in a clinical trial) study in healthy women. The study consists of 3 parts: Screening phase, Treatment phase and end-of-study or withdrawal. Treatment periods will be separated by a wash out period of at least 10 days. The duration of participation in the study for an individual participant will be approximately 7 weeks. All participants will be randomly assigned in a 1:1 ratio to 1 of 2 possible treatment sequences and receive both of the following treatments: 1 oral tablet formulated by wet process or dry process, whereas each tablet contains norgestimate 250 microgram (mcg) and ethinyl estradiol 35 mcg. The primary endpoint of the study will be assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

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.
101

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

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

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:

  • Participants must be either surgically sterile or of child-bearing potential and be practicing an effective non-hormonal method of birth control (for example, copper intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study
  • If a woman of child-bearing potential, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of the each treatment period
  • Participants must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last dose
  • Body mass index (BMI: weight [kilogram {kg}]/height^2 [meter {m}]^2) between 18.5 and 30 kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg) or higher than 90 kg (198 pounds)
  • Participant must be a non-smoker

Exclusion Criteria:

  • Participants have a levonorgestrel implant (for example, Norplant) in place or removed within the 30 days before admission to the study site
  • Contraindications to combined hormonal contraceptives
  • Participants who received medroxyprogesterone injection (for example, Depo Provera) within 6 months of admission to the study
  • Use of any other hormonal contraceptive within 30 days of admission to the study site
  • Participants with abnormal papanicolaou (Pap) smear or CytoRich test

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover 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.
Experimental: First NGM/EE (Wet Process), then NGM/EE (Dry Process)
Participants will receive 1 tablet (formulated by wet process) containing norgestimate 250 microgram (mcg) and ethinyl estradiol 35 mcg, orally on Day 1 of Period 1, followed by 1 tablet (formulated by dry process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 2, wherein Period 1 and Period 2 are separated by a wash out period of at least 10 days.
Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)
Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by wet process will be orally administered on Day 1 of Period 1 or Period 2.
Other Names:
  • Cyclen
  • Tri Cyclen
  • Cilest
  • Tri-Cilest
Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by dry process will be orally administered on Day 1 of Period 1 or Period 2.
Other Names:
  • Ortho Cyclen
  • Ortho Tri Cyclen
Experimental: First NGM/EE (Dry Process), then NGM/EE (Wet Process)
Participants will receive 1 tablet (formulated by dry process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 1, followed by 1 tablet (formulated by wet process) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, orally on Day 1 of Period 2, wherein Period 1 and Period 2 are separated by a wash out period of at least 10 days.
Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)
Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by wet process will be orally administered on Day 1 of Period 1 or Period 2.
Other Names:
  • Cyclen
  • Tri Cyclen
  • Cilest
  • Tri-Cilest
Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by dry process will be orally administered on Day 1 of Period 1 or Period 2.
Other Names:
  • Ortho Cyclen
  • Ortho Tri Cyclen

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 Plasma Concentration (C[max])
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
The C(max) is the maximum serum concentration which will be observed at the defined time points.
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
The AUC (last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

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
Time to Reach the Maximum Plasma Concentration (T[max])
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
The T[max] is time to reach the observed maximum plasma concentration.
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Percentage of AUC(0-infinity)
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Percentage of AUC(0-infinity) is calculated as (AUC[0-infinity] minus AUC[0-last] divided by AUC[0-infinity]) multiplied by 100.
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Elimination Half-life Period (t1/2)
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Terminal slope (Lambda [z])
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Coefficient of Determination (r^2)
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
The coefficient of determination is a goodness of fit statistic that gives the proportion of the variance of one variable that is predictable from the other variable.
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
Adjusted Coefficient of Determination (r^2 adj.)
Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2
The coefficient of determination adjusted (r^2 adj.) for the number of points used in the estimation of lambda[z].
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 72 hours after study drug administration on Day 1 of Period 1 and Period 2

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.
Janssen Research & Development, LLC

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.
June 1, 2013

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.
September 1, 2014

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.
September 1, 2014

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).
April 29, 2014

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 29, 2014

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 30, 2014

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.
October 3, 2014

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.
October 2, 2014

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.
October 1, 2014

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.
  • CR104172
  • 10131CON1001 (Other Identifier: Janssen Research & Development, LLC)
  • 2014-000983-16 (EudraCT Number)

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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