HealthyPhase 1NCT01344369

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions

A Phase 1 study testing Norethindrone/Ethinyl Estradiol and FEMCON® Fe in people with Healthy, run by Teva Pharmaceuticals USA 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

The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol and ferrous fumarate) 0.4 mg/0.035 mg… 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?: Norethindrone/Ethinyl Estradiol and FEMCON® Fe
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Sep 2008
Phase: Phase 1
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

Females, 18-45 years of age inclusive with Body Mass Index within 18-30 kg/m2 inclusive, as described in Novum Standard Operating Procedures. Female subjects must either abstain from sexual intercourse or use a reliable non-hormonal method of contraception (e.g. condom with spermicide, diaphragm, non-hormonal IUD) from at least 14 days prior to the first study dosing, throughout the study, and until 14 days after the last dose.
Normal menstrual cycle.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Who cannot join

Post menopausal or have irregular menstrual cycle.
Pregnant, lactating, or likely to become pregnant during the study.
History of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
Significant history or current evidence of chronic infectious disease, system disorder, or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of psychiatric disorders occurring within the last two years that required hospitalization or medication.

Show all 23Show fewer

Presence of a medical condition requiring regular treatment with prescription drugs.
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Participation in any clinical trial within 30 days prior to dosing.
Drug or alcohol addiction requiring treatment in the past 12 months.
Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.
Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
Positive test results for drugs of abuse at screening.
Positive serum pregnancy test.
Subjects who have ever had progestational hormone implants.
Subjects who have had progestational hormone depot injections within 12 months proceeding dosing.
Subjects who are using or have used within the 3 months preceding dosing any vaginally administered estrogen or progestin-containing products.
Any personal or strong family history of estrogen- or progestogen-dependent tumors.
History of clinically significant fibrocystic breast disease.
Subjects with a history of thromboembolic disorders, myocardial infarction, or stroke.
Use of norethindrone or ethinyl estrodiol-containing oral contraceptives within 30 days of initial dosing.
Hysterectomy or oophorectomy (unilateral or bilateral)
User of tobacco or nicotine containing products within 30 days of the start of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Novum Pharmaceutical Research Services
Houston, Texas, 77042-4712

Other trials in United States

About this study

Official title: A Study to Evaluate the Relative Bioavailability of Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva Pharmaceuticals, USA) Compared to FEMCON® Fe (Norethindrone/Ethinyl Estradiol) 0.4 mg/0.035 mg Chewable Tablets (Warner Chilcott) in Healthy Female Volunteers Under Non-Fasted Conditions

Conditions: Healthy
Being tested: Norethindrone/Ethinyl Estradiol, FEMCON® Fe
Keywords: Healthy Subjects, Bioequivalence

What participants receive

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

Norethindrone/Ethinyl EstradiolDrug
Also called Zeosa®
0.4 mg/0.035 mg Chewable Tablets
FEMCON® FeDrug
Also called Ovcon® 35 Fe, norethindrone/ethinyl estradiol (generic name)
0.4 mg/0.035 mg Chewable Tablets

Study groups in NCT01344369
Study group	Role	What they receive
Investigational Test Product	Experimental	Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva) Receives: Drug: Norethindrone/Ethinyl Estradiol
Reference Listed Drug	Active comparator	FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) Receives: Drug: FEMCON® Fe

What is being measured

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

Cmax of Norethindrone
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Measured: Blood samples collected over a 60 hour period.
AUC0-t of Norethindrone
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Measured: Blood samples collected over a 60 hour period.
AUC0-inf of Norethindrone
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
Measured: Blood samples collected over a 60 hour period.
Cmax of Ethinyl Estradiol
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
Measured: Blood samples collected over a 60 hour period.
AUC0-t of Ethinyl Estradiol
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Measured: Blood samples collected over a 60 hour period.
AUC0-inf of Ethinyl Estradiol
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).
Measured: Blood samples collected over a 60 hour period.

Timeline

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

Aug 2008Sep 2008

First posted29 Apr 2011 (estimated)
Study startAug 2008
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01344369
Sponsor's protocol ID: 10816221
Status last verified: May 2011
First submitted: 27 Apr 2011
Last updated: 30 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Relative Bioavailability of Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva Pharmaceuticals, USA) Compared to FEMCON® Fe (Norethindrone/Ethinyl Estradiol) 0.4 mg/0.035 mg Chewable Tablets (Warner Chilcott) in Healthy Female Volunteers Under Non-Fasted Conditions
ClinicalTrials.gov ID: NCT01344369
Acronym / sponsor ID: 10816221
Conditions: Healthy
Keywords: Healthy Subjects, Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 29 Apr 2011 (estimated)
Results: Posted 30 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Investigational Test Product	Experimental	Drug: Norethindrone/Ethinyl EstradiolNorethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva)
Reference Listed Drug	Active comparator	Drug: FEMCON® FeFEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Females, 18-45 years of age inclusive with Body Mass Index within 18-30 kg/m2 inclusive, as described in Novum Standard Operating Procedures. Female subjects must either abstain from sexual intercourse or use a reliable non-hormonal method of contraception (e.g. condom with spermicide, diaphragm, non-hormonal IUD) from at least 14 days prior to the first study dosing, throughout the study, and until 14 days after the last dose.
Normal menstrual cycle.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Key exclusion criteria (23 listed)

Post menopausal or have irregular menstrual cycle.
Pregnant, lactating, or likely to become pregnant during the study.
History of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
Significant history or current evidence of chronic infectious disease, system disorder, or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.

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
Norethindrone/Ethinyl EstradiolAlso: Zeosa®0.4 mg/0.035 mg Chewable Tablets	Drug	Investigational Test Product
FEMCON® FeAlso: Ovcon® 35 Fe, norethindrone/ethinyl estradiol (generic name)0.4 mg/0.035 mg Chewable Tablets	Drug	Reference Listed Drug

Primary outcome

Cmax of Norethindrone
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Norethindrone
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf of Norethindrone
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
Cmax of Ethinyl Estradiol
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Ethinyl Estradiol
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf of Ethinyl Estradiol
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).

Results and safety

Results posted to the registry on 30 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Norethindrone/Ethinyl Estradiol (Test) First	18	18
FEMCON® Fe (Reference) First	18	18

Primary outcome: Cmax of Norethindrone

Time frame: Blood samples collected over a 60 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Norethindrone/Ethinyl Estradiol (Test) n = 33	FEMCON® Fe (Reference) n = 33
Value	4.3306 (1.7393)	4.2282 (1.6696)

Norethindrone/Ethinyl Estradiol (Test) vs FEMCON® Fe (Reference): Ratio of the T/R geometric mean x 100: 102.44 (90% CI 93.08 to 112.75)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-t of Norethindrone

Time frame: Blood samples collected over a 60 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Norethindrone/Ethinyl Estradiol (Test) n = 33	FEMCON® Fe (Reference) n = 33
Value	37.8065 (16.1921)	37.3991 (15.3939)

Norethindrone/Ethinyl Estradiol (Test) vs FEMCON® Fe (Reference): Ratio of the T/R geometric mean x 100: 100.58 (90% CI 96.66 to 104.66)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-inf of Norethindrone

Time frame: Blood samples collected over a 60 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Norethindrone/Ethinyl Estradiol (Test) n = 33	FEMCON® Fe (Reference) n = 33
Value	43.9982 (19.4559)	43.8819 (18.8478)

Norethindrone/Ethinyl Estradiol (Test) vs FEMCON® Fe (Reference): Ratio of the T/R geometric mean x 100: 100.85 (90% CI 96.43 to 105.48)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: Cmax of Ethinyl Estradiol

Time frame: Blood samples collected over a 60 hour period.. Mean (Standard Deviation). Unit: pg/mL

Measure	Norethindrone/Ethinyl Estradiol (Test) n = 33	FEMCON® Fe (Reference) n = 33
Value	137.6758 (33.6231)	137.8485 (37.6177)

Norethindrone/Ethinyl Estradiol (Test) vs FEMCON® Fe (Reference): Ratio of the T/R geometric mean x 100: 100.59 (90% CI 93.69 to 108.00)

Population analysed: All participants that completed the study had their samples analyzed.

Adverse events

Time frame: Adverse event data was collected over the course of the study, which was approximately 6 weeks in duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Norethindrone/Ethinyl Estradiol (Test)	0 of 36 (0%)	13 of 36 (36.1%)	Not reported
FEMCON® Fe (Reference)	0 of 36 (0%)	10 of 36 (27.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Norethindrone/Ethinyl Estradiol and FEMCON® Fe in people with Healthy, run by Teva Pharmaceuticals USA 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 4 inclusion and 23 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 30 May 2011. 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 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?

Yes. Results are posted in the registry (first posted 30 May 2011). 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?

Cmax of Norethindrone (time frame: Blood samples collected over a 60 hour period.). The study lists 6 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 NCT01344369.

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 30 May 2011.