HealthyPhase 1NCT01182207

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions

A Phase 1 study testing Drospirenone/Ethinyl Estradiol (Gianvi®) and YAZ® 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

Search all trials

Trial summary

This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult subjects under non-fasting conditions. Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Drospirenone/Ethinyl Estradiol (Gianvi®) and YAZ®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Jul 2006to Aug 2006
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 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing.
Subjects who completed the screening process within 28 days prior to Period I dosing.
Subjects who were healthy, adult, menstruating women 18 to 35 years of age, inclusive, at the time of dosing.
Subjects with a body mass index (BMI) between 19 and 30 kg/m2, inclusive, and weighed at least 110 pounds.
Subjects who were healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram, clinical laboratory assessments, and by general observations. The physical examination also included a gynecological exam. If the subject had completed an acceptable Pap smear and gynecological exam in the previous 12 months (prior to study Day 1) and the documentation of acceptable results were provided, both were deferred. Any abnormalities/deviations from thee normal range which were considered clinically relevant by the study physician and investigator were evaluated for individual cases, documented in study files, and agreed upon by the study physician and investigator prior to enrolling a volunteer in the study and for continued enrollment.
Female subjects who practice an acceptable non-hormonal method of birth control as judged by the investigator(s) at least 14 days prior to Period I dosing, throughout the study, and until 14 days after Period II dosing. The acceptable non-hormonal birth control methods included: double barriers, non-hormone releasing intrauterine device in place for at least 30 days prior to dosing, abstinence throughout the duration of the study, or surgically sterile for at least 6 months prior to Period I dosing.

Who cannot join

Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
Volunteers who reported taking any oral contraceptives including estrogen and progestin combined pills and progestin only pills or patch within 28 days prior to Period I dosing, or using injectable contraceptives within 6 months of Period I dosing.
Volunteers who have ever had progestational hormone implants.
Volunteers who reported any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, liver, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s), or psychiatric or epilepsy disease as determined by the clinical investigator(s).
Volunteers who reported any presence or history of migraines or severe headaches.
Volunteers who had a systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 45 or over 90 mmHg were excluded from the study.

Show all 27Show fewer

Volunteers who had a history of thrombotic disorders, have ever had a cerebrovascular accident, or had transient ischemic attacks.
Volunteers with a history of breast cancer or undiagnosed breast nodules, active malignancies, or undiagnosed vaginal bleeding.
Volunteers having other conditions that may be aggravated by fluid retention (as determined by principle investigator).
Volunteers who had a history of jaundice with previous use of oral contraceptives or any other kinds of hormonal contraceptives.
Volunteers whose clinical laboratory test values outside the acceptable range and when confirmed on re-examination were deemed to be clinically significant.
Volunteers who demonstrated a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
Volunteers who reported a history of allergic response(s) to drospirenone/ethinyl estradiol, progestin/estrogens, or related drugs.
Volunteers who reported the use of any systemic prescription medications in the 14 days prior to Period 1 dosing (with the exception of hormonal contraceptives).
Volunteers who reported the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
Volunteers who reported a history of clinically significant allergies including drug allergies.
Volunteers who reported a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
Volunteers who reported a history of drug or alcohol addiction or abuse within the past year.
Volunteers who demonstrated a positive drug abuse screen for the study prior to Period I dose administration.
Volunteers who used tobacco products in the past 6 months.
Volunteers who reported donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects were advised not to donate blood for 4 weeks after completing the study.
Volunteers who reported donating plasma within 30 days prior to Period I dosing. All subjects were advised not to donate blood for 4 weeks after completing the study.
Volunteers who demonstrate a positive pregnancy screen.
Volunteers who were currently breastfeeding.
Subjects who had used within the 3 months preceding Period I dosing any vaginally administered estrogen or progestin containing products.
Any volunteer who engaged in unprotected sexual intercourse during the time interval starting 14 days prior to the first period until 14 days after Period II dosing.
Volunteers who had a hysterectomy or oophorectomy.

Trial locations and contacts

1 site in 1 country.

United States1 site

PRACS Institute, Ltd.
Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Non-Fasting Conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions: Healthy
Being tested: Drospirenone/Ethinyl Estradiol (Gianvi®), YAZ®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

Drospirenone/Ethinyl Estradiol (Gianvi®)Drug
Also called Gianvi®
3 mg/0.02 mg Tablets
YAZ®Drug
Also called Drospirenone/Ethinyl Estradiol (generic name)
3 mg/0.02 mg Tablets

Study groups in NCT01182207
Study group	Role	What they receive
Investigational Test Product	Experimental	Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg Receives: Drug: Drospirenone/Ethinyl Estradiol (Gianvi®)
Reference Listed Drug	Active comparator	YAZ® Tablets, 3 mg/0.02 mg Receives: Drug: YAZ®

What is being measured

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

Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Drospirenone Cmax.
Measured: Blood samples collected over a 120 hour period.
AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Drospirenone AUC0-t.
Measured: Blood samples collected over a 120 hour period.
AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Drospirenone AUC0-inf.
Measured: Blood samples collected over a 120 hour period.
Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Ethinyl Estradiol Cmax.
Measured: Blood samples collected over a 72 hour period.
AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Ethinyl Estradiol AUC0-t.
Measured: Blood samples collected over a 72 hour period.
AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Ethinyl Estradiol AUC0-inf.
Measured: Blood samples collected over a 72 hour period.

Timeline

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

Jul 2006Aug 2006

First posted16 Aug 2010 (estimated)
Study startJul 2006
Primary completionAug 2006
Study completionAug 2006

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: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01182207
Sponsor's protocol ID: R06-0632
Status last verified: Nov 2010
First submitted: 12 Aug 2010
Last updated: 8 Dec 2010
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 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Non-Fasting Conditions.
ClinicalTrials.gov ID: NCT01182207
Acronym / sponsor ID: R06-0632
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Aug 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 16 Aug 2010 (estimated)
Results: Posted 7 Oct 2010

Clinical summary

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

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study design

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

Arm	Type	Receives
Investigational Test Product	Experimental	Drug: Drospirenone/Ethinyl Estradiol (Gianvi®)Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg
Reference Listed Drug	Active comparator	Drug: YAZ®YAZ® Tablets, 3 mg/0.02 mg

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing.
Subjects who completed the screening process within 28 days prior to Period I dosing.
Subjects who were healthy, adult, menstruating women 18 to 35 years of age, inclusive, at the time of dosing.
Subjects with a body mass index (BMI) between 19 and 30 kg/m2, inclusive, and weighed at least 110 pounds.
Subjects who were healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram, clinical laboratory assessments, and by general observations. The physical examination also included a gynecological exam. If the subject had completed an acceptable Pap smear and gynecological exam in the previous 12 months (prior to study Day 1) and the documentation of acceptable results were provided, both were deferred. Any abnormalities/deviations from thee normal range which were considered clinically relevant by the study physician and investigator were evaluated for individual cases, documented in study files, and agreed upon by the study physician and investigator prior to enrolling a volunteer in the study and for continued enrollment.

Key exclusion criteria (27 listed)

Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
Volunteers who reported taking any oral contraceptives including estrogen and progestin combined pills and progestin only pills or patch within 28 days prior to Period I dosing, or using injectable contraceptives within 6 months of Period I dosing.
Volunteers who have ever had progestational hormone implants.
Volunteers who reported any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, liver, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s), or psychiatric or epilepsy disease as determined by the clinical investigator(s).
Volunteers who reported any presence or history of migraines or severe headaches.

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
Drospirenone/Ethinyl Estradiol (Gianvi®)Also: Gianvi®3 mg/0.02 mg Tablets	Drug	Investigational Test Product
YAZ®Also: Drospirenone/Ethinyl Estradiol (generic name)3 mg/0.02 mg Tablets	Drug	Reference Listed Drug

Primary outcome

Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on Drospirenone Cmax.
AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on Drospirenone AUC0-t.
AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on Drospirenone AUC0-inf.
Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Ethinyl Estradiol Cmax.
AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Ethinyl Estradiol AUC0-t.
AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Ethinyl Estradiol AUC0-inf.

Results and safety

Results posted to the registry on 7 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drospirenone/Ethinyl Estradiol (Test) First	18	18
YAZ® (Reference) First	15	14

Primary outcome: Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 120 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Drospirenone/Ethinyl Estradiol (Test) n = 31	YAZ® (Reference) n = 31
Value	52.77 (15.77)	53.65 (13.82)

Drospirenone/Ethinyl Estradiol (Test) vs YAZ® (Reference): Ratio of the T/R geometric mean x 100: 96.74 (90% CI 86.82 to 107.79)

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

Primary outcome: AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Time frame: Blood samples collected over a 120 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Drospirenone/Ethinyl Estradiol (Test) n = 31	YAZ® (Reference) n = 31
Value	889.67 (187.51)	867.10 (207.11)

Drospirenone/Ethinyl Estradiol (Test) vs YAZ® (Reference): Ratio of the T/R geometric mean x 100: 103.16 (90% CI 101.10 to 105.27)

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

Primary outcome: AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)

Time frame: Blood samples collected over a 120 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Drospirenone/Ethinyl Estradiol (Test) n = 31	YAZ® (Reference) n = 31
Value	951.18 (226.13)	930.38 (236.38)

Drospirenone/Ethinyl Estradiol (Test) vs YAZ® (Reference): Ratio of the T/R geometric mean x 100: 102.72 (90% CI 100.67 to 104.80)

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

Primary outcome: Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 72 hour period.. Mean (Standard Deviation). Unit: pg/mL

Measure	Drospirenone/Ethinyl Estradiol (Test) n = 31	YAZ® (Reference) n = 31
Value	87.95 (29.22)	91.23 (36.79)

Drospirenone/Ethinyl Estradiol (Test) vs YAZ® (Reference): Ratio of the T/R geometric mean x 100: 97.60 (90% CI 89.45 to 106.50)

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
Drospirenone/Ethinyl Estradiol (Test)	0 of 33 (0%)	21 of 33 (63.6%)	Not reported
YAZ® (Reference)	0 of 33 (0%)	11 of 33 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
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.

Anthony R Godfrey, Pharm.D. principal investigator

PRACS Institute, Ltd.

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 Drospirenone/Ethinyl Estradiol (Gianvi®) and YAZ® 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 6 inclusion and 27 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 8 Dec 2010. 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 7 Oct 2010). 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 Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 120 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 NCT01182207.

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 8 Dec 2010.