HealthyPhase 1NCT02127593
A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities
A Phase 1 study testing Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process) and Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial summary
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. 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
- Healthy
- What is being tested?
- Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process) and Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process), Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
- Keywords
- Norgestimate, Ethinyl estradiol, Norgestrel, Norelgestromin, Ortho cyclen, Phase 1, Healthy Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)Drug
Also called Cyclen, Tri Cyclen, Cilest, Tri-Cilest
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.
Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)Drug
Also called Ortho Cyclen, Ortho Tri Cyclen
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.
| Study group | Role | What they receive |
|---|---|---|
| First NGM/EE (Wet Process), then NGM/EE (Dry Process) | Experimental | 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. Receives: Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process); Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process) |
| First NGM/EE (Dry Process), then NGM/EE (Wet Process) | Experimental | 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. Receives: Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process); Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (C[max])
The C(max) is the maximum serum concentration which will be observed at the defined time points.
Measured: 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])
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.
Measured: 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])
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.
Measured: 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 outcomes (6)
Time to Reach the Maximum Plasma Concentration (T[max])
The T[max] is time to reach the observed maximum plasma concentration.
Measured: 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)
Percentage of AUC(0-infinity) is calculated as (AUC[0-infinity] minus AUC[0-last] divided by AUC[0-infinity]) multiplied by 100.
Measured: 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)
Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).
Measured: 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])
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.
Measured: 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)
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.
Measured: 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.)
The coefficient of determination adjusted (r^2 adj.) for the number of points used in the estimation of lambda[z].
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trials, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127593
- Sponsor's protocol ID
- CR104172
- Other IDs
- 10131CON1001, 2014-000983-16, 2014
- Status last verified
- Oct 2014
- First submitted
- 29 Apr 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities
- ClinicalTrials.gov ID
- NCT02127593
- Acronym / sponsor ID
- CR104172
- Conditions
- Healthy
- Keywords
- Norgestimate, Ethinyl estradiol, Norgestrel, Norelgestromin, Ortho cyclen, Phase 1, Healthy Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First NGM/EE (Wet Process), then NGM/EE (Dry Process) | Experimental | Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process), Drug: Norgestimate /Ethinyl estradiol tablets (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. |
| First NGM/EE (Dry Process), then NGM/EE (Wet Process) | Experimental | Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process), Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)Also: Cyclen, Tri Cyclen, Cilest, Tri-CilestNorgestimate /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. | Drug | First NGM/EE (Dry Process), then NGM/EE (Wet Process), First NGM/EE (Wet Process), then NGM/EE (Dry Process) |
| Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)Also: Ortho Cyclen, Ortho Tri CyclenNorgestimate /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. | Drug | First NGM/EE (Dry Process), then NGM/EE (Wet Process), First NGM/EE (Wet Process), then NGM/EE (Dry Process) |
Primary outcome
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.
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.
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trials study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process) and Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
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 5 inclusion and 5 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 3 Oct 2014. 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2014.