Prevention of PregnancyPhase 3NCT00932321

Study of Safety and Efficacy of an Oral Contraceptive

A Phase 3 study testing Norethindrone Acetate/Ethinyl Estradiol 24 Days and Norethindrone Acetate /Ethinyl Estradiol 21 Days in people with Prevention of Pregnancy, run by Warner Chilcott at 34 sites 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

This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and… 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: Prevention of Pregnancy
What is being tested?: Norethindrone Acetate/Ethinyl Estradiol 24 Days and Norethindrone Acetate /Ethinyl Estradiol 21 Days
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 938 participants
Where: 34 sitesUnited States
Study dates: Jan 2004to Nov 2004
Phase: Phase 3
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

Healthy Women
Age 18-45
At risk for pregnancy
History of regular cycles

Who cannot join

Contraindications for use of hormonal contraception
Conditions which affect the absorption or metabolism of steroid hormones
BMI > 35

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Warner Chilcott Investigational Site
Allentown, Pennsylvania, 18104
Warner Chilcott Investigational Site
Birmingham, Alabama, 35233
Warner Chilcott Investigational Site
Boynton Beach, Florida, 33437
Warner Chilcott Investigational Site
Charleston, South Carolina, 29425
Warner Chilcott Investigational Site
Chico, California, 95929
Warner Chilcott Investigational Site
Decatur, Georgia, 30033
Warner Chilcott Investigational Site
Decatur, Georgia, 30034
Warner Chilcott Investigational Site
Denver, Colorado, 80202
Warner Chilcott Investigational Site
Greenville, South Carolina, 29605
Warner Chilcott Investigational Site
Jacksonville, Florida, 32207
Warner Chilcott Investigational Site
Kansas City, Missouri, 64112
Warner Chilcott Investigational Site
Los Angeles, California, 90033
Warner Chilcott Investigational Site
Louisville, Kentucky, 40202
Warner Chilcott Investigational Site
Miami, Florida, 33186
Warner Chilcott Investigational Site
New Bern, North Carolina, 28562
Warner Chilcott Investigational Site
Norfolk, Virginia, 23507
Warner Chilcott Investigational Site
Palm Harbor, Florida, 34684
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, 19114
Warner Chilcott Investigational Site
Phoenix, Arizona, 85014
Warner Chilcott Investigational Site
Phoenix, Arizona, 85031
Warner Chilcott Investigational Site
Pittsburgh, Pennsylvania, 15206
Warner Chilcott Investigational Site
Powder Springs, Georgia, 30127
Warner Chilcott Investigational Site
Richmond, Virginia, 23233
Warner Chilcott Investigational Site
Roswell, Georgia, 30075
Warner Chilcott Investigational Site
San Diego, California, 92103
Warner Chilcott Investigational Site
San Diego, California, 92108
Warner Chilcott Investigational Site
Sandy City, Utah, 84070
Warner Chilcott Investigational Site
Savannah, Georgia, 31405
Warner Chilcott Investigational Site
Seattle, Washington, 98105
Warner Chilcott Investigational Site
St Louis, Missouri, 63117
Warner Chilcott Investigational Site
Venice, Florida, 34285
Warner Chilcott Investigational Site
Virginia Beach, Virginia, 23456
Warner Chilcott Investigational Site
West Palm Beach, Florida, 33409
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

Conditions: Prevention of Pregnancy
Being tested: Norethindrone Acetate/Ethinyl Estradiol 24 Days, Norethindrone Acetate /Ethinyl Estradiol 21 Days
Keywords: Contraception

What participants receive

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

Norethindrone Acetate/Ethinyl Estradiol 24 DaysDrug
One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
Norethindrone Acetate /Ethinyl Estradiol 21 DaysDrug
Also called 21 Day NA/EE
One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Study groups in NCT00932321
Study group	Role	What they receive
24 Day NA/EE	Experimental	Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle Receives: Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days
21 Day NA/EE	Active comparator	Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle Receives: Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days

What is being measured

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

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population
Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment
Measured: 5.6 months (6 - 28 day cycles)

Secondary outcomes (1)

Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.
Measured: 5.6 months (6 - 28 day cycles)

Timeline

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

Jan 2004Nov 2004

First posted3 Jul 2009 (estimated)
Study startJan 2004
Primary completionNov 2004
Study completionNov 2004

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 Prevention of PregnancyStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 938 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00932321
Sponsor's protocol ID: PR-03903
Status last verified: Apr 2013
First submitted: 30 Jun 2009
Last updated: 22 Apr 2013
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?

See locations

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Use Misoprostol to Optimize Prevention of Cervical Cancer
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All Prevention of Pregnancy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)
ClinicalTrials.gov ID: NCT00932321
Acronym / sponsor ID: PR-03903
Conditions: Prevention of Pregnancy
Keywords: Contraception
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 938 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Nov 2004 (actual)
Study completion: Nov 2004 (actual)
First posted: 3 Jul 2009 (estimated)
Results: Posted 22 Mar 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

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
24 Day NA/EE	Experimental	Drug: Norethindrone Acetate/Ethinyl Estradiol 24 DaysNorethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle
21 Day NA/EE	Active comparator	Drug: Norethindrone Acetate /Ethinyl Estradiol 21 DaysNorethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy Women
Age 18-45
At risk for pregnancy
History of regular cycles

Key exclusion criteria (3 listed)

Contraindications for use of hormonal contraception
Conditions which affect the absorption or metabolism of steroid hormones
BMI > 35

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 Acetate/Ethinyl Estradiol 24 DaysOne tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets	Drug	24 Day NA/EE
Norethindrone Acetate /Ethinyl Estradiol 21 DaysAlso: 21 Day NA/EEOne tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets	Drug	21 Day NA/EE

Primary outcome

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population
Time frame: 5.6 months (6 - 28 day cycles)
Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment

1 secondary outcome

Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
Time frame: 5.6 months (6 - 28 day cycles)

Results and safety

Results posted to the registry on 22 Mar 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
24 Day NA/EE	751	580
21 Day NA/EE	187	141

Primary outcome: Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population

Time frame: 5.6 months (6 - 28 day cycles). Number. Unit: Pearl Index

Measure	24 Day NA/EE n = 705	21 Day NA/EE n = 181
Value	1.823	2.978

Population analysed: Modified intention to treat (MITT) subset of all treat subjects - evaluated for pregnancy at least once after beginning study medication.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 10 months, between 5 Feb 2004 and 30 Nov 2004. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
24 Day NA/EE	3 of 743 (0.4%)	457 of 743 (61.5%)	Not reported
21 Day NA/EE	0 of 186 (0%)	99 of 186 (53.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prevention of Pregnancy

Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Recruiting
Use Misoprostol to Optimize Prevention of Cervical Cancer
Cervical Cancers
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage

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.

Herman Ellman, MD study director

Sponsor GmbH

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Mar 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?

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population (time frame: 5.6 months (6 - 28 day cycles)). 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 NCT00932321.

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 22 Apr 2013.