ContraceptionPhase 3NCT00391807

Study of Safety and Efficacy of an Oral Contraceptive

A Phase 3 study testing Norethindrone acetate/ethinyl estradiol in people with Contraception, run by Warner Chilcott at 66 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 non-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; and to assess the safety and tolerability of the product. 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: Contraception
What is being tested?: Norethindrone acetate/ethinyl estradiol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,683 participants
Where: 66 sitesUnited States
Study dates: Nov 2006to Sep 2008
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

66 sites in 1 country.

City, postcode or hospital

66 sites in 1 country

United States66 sites

Warner Chilcott Investigational Site
Albuquerque, New Mexico, 87102
Warner Chilcott Investigational Site
Berlin, New Jersey, 08009
Warner Chilcott Investigational Site
Boynton Beach, Florida, 33437
Warner Chilcott Investigational Site
Carmichael, California, 95608
Warner Chilcott Investigational Site
Cary, North Carolina
Warner Chilcott Investigational Site
Champaign, Illinois, 61820
Warner Chilcott Investigational Site
Charleston, South Carolina, 29401
Warner Chilcott Investigational Site
Clearwater, Florida, 33759
Warner Chilcott Investigational Site
Cleveland, Ohio, 44122
Warner Chilcott Investigational Site
Columbia, South Carolina, 29201
Warner Chilcott Investigational Site
Columbus, Ohio, 43213
Warner Chilcott Investigational Site
Dallas, Texas
Warner Chilcott Investigational Site
Denver, Colorado, 80218
Warner Chilcott Investigational Site
Greenville, South Carolina, 29615
Warner Chilcott Investigational Site
Houston, Texas, 77030
Warner Chilcott Investigational Site
Indianapolis, Indiana
Warner Chilcott Investigational Site
Jacksonville, Florida, 32207
Warner Chilcott Investigational Site
Lawrenceville, New Jersey, 08648
Warner Chilcott Investigational Site
Leesburg, Florida, 34748
Warner Chilcott Investigational Site
Lexington, Kentucky, 40509
Warner Chilcott Investigational Site
Longwood, Florida, 32779
Warner Chilcott Investigational Site
Louisville, Kentucky, 40202
Warner Chilcott Investigational Site
Louisville, Kentucky, 40291
Warner Chilcott Investigational Site
Magna, Utah, 84044
Warner Chilcott Investigational Site
Miami, Florida, 33143
Warner Chilcott Investigational Site
Miami, Florida, 33186
Warner Chilcott Investigational Site
Moorestown, New Jersey, 08057
Warner Chilcott Investigational Site
New Bern, North Carolina, 28562
Warner Chilcott Investigational Site
New Port Richey, Florida, 34652
Warner Chilcott Investigational Site
Norfolk, Virginia, 23507-1627
Warner Chilcott Investigational Site
Oklahoma City, Oklahoma, 73112
Warner Chilcott Investigational Site
Pembroke Pines, Florida
Warner Chilcott Investigational Site
Peoria, Illinois, 61615
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, 19114
Warner Chilcott Investigational Site
Phoenix, Arizona, 85014
Warner Chilcott Investigational Site
Phoenix, Arizona, 85015
Warner Chilcott Investigational Site
Phoenix, Arizona, 85032
Warner Chilcott Investigational Site
Phoenix, Arizona, 85050
Warner Chilcott Investigational Site
Pittsburgh, Pennsylvania, 15206
Warner Chilcott Investigational Site
Plantation, Florida, 33324
Warner Chilcott Investigational Site
Portland, Oregon, 97210
Warner Chilcott Investigational Site
Portland, Oregon, 97239
Warner Chilcott Investigational Site
Pottstown, Pennsylvania, 19464-3224
Warner Chilcott Investigational Site
Raleigh, North Carolina, 27609
Warner Chilcott Investigational Site
Richmond, Virginia, 23233
Warner Chilcott Investigational Site
Roswell, Georgia, 30075
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84017
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84109
Warner Chilcott Investigational Site
San Antonio, Texas, 78229
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
Sandy Springs, Georgia, 30328
Warner Chilcott Investigational Site
Seattle, Washington, 98105
Warner Chilcott Investigational Site
Spokane, Washington, 99207
Warner Chilcott Investigational Site
St. Petersburg, Florida, 33709
Warner Chilcott Investigational Site
Tacoma, Washington, 98405
Warner Chilcott Investigational Site
Tempe, Arizona, 85283
Warner Chilcott Investigational Site
Tempe, Arizona
Warner Chilcott Investigational Site
Tucson, Arizona, 85712
Warner Chilcott Investigational Site
Virginia Beach, Virginia, 23456
Warner Chilcott Investigational Site
West Palm Beach, Florida, 33401
Warner Chilcott Investigational Site
West Palm Beach, Florida
Warner Chilcott Investigational Site
Wichita, Kansas
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103
Warner Chilcott Investigational Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol

Conditions: Contraception
Being tested: Norethindrone acetate/ethinyl estradiol
Keywords: Contraception

What participants receive

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

Norethindrone acetate/ethinyl estradiolDrug
one tablet per day

Study groups in NCT00391807
Study group	Role	What they receive
study drug	Experimental	Norethindrone/Ethinyl Estradiol Receives: Drug: Norethindrone acetate/ethinyl estradiol

What is being measured

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

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,
Measured: 13 cycles, 28 days each (1 year)
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population
Measured: 13 Cycles, 28 days each (1 year)

Secondary outcomes (15)

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population
MITT Population
Measured: 2 Cycles, 28 days each (56 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population
MITT Population
Measured: 6 cycles, 28 days each (168 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population
MITT Population
Measured: 13 cycles, 28 days each (1 year)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population
Measured: 2 cycles, 28 days each (56 days)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population
Measured: 6 cycles, 28 days each (168 days)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population
Measured: 13 cycles, 28 days each (1 year)
Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population
Measured: 2 cycles, 28 days each (56 days)
Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population
Measured: 6 cycles, 28 days each (168 days)
Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population
Measured: 12 cycles, 28 days each (336 days)
Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population
Measured: 2 cycles, 28 days each (56 days)
Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population
Measured: 6 cycles, 28 days each (168 days)
Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population
Measured: 13 cycles, 28 days each (1 year)
Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population
Measured: 2 cycles, 28 days each (56 days)
Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population
Measured: 6 cycles, 28 days each (168 days)
Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population
Measured: 13 cycles, 28 days each (1 year)

Timeline

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

Nov 2006Sep 2008

First posted24 Oct 2006 (estimated)
Study startNov 2006
Primary completionAug 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,683 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00391807
Sponsor's protocol ID: PR-05806
Status last verified: Apr 2013
First submitted: 20 Oct 2006
Last updated: 22 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nakajima ST, Pappadakis J, Archer DF. Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive. Contraception. 2016 Jan;93(1):52-7. doi: 10.1016/j.contraception.2015.09.013. Epub 2015 Sep 26.
PubMed 26410176
Archer DF, Nakajima ST, Sawyer AT, Wentworth J, Trupin S, Koltun WD, Gilbert RD, Ellman H. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive. Obstet Gynecol. 2013 Sep;122(3):601-7. doi: 10.1097/AOG.0b013e3182a1741c.
PubMed 23921878

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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All Contraception 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 Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol
ClinicalTrials.gov ID: NCT00391807
Acronym / sponsor ID: PR-05806
Conditions: Contraception
Keywords: Contraception
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,683 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Aug 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 24 Oct 2006 (estimated)
Results: Posted 22 Dec 2010

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
study drug	Experimental	Drug: Norethindrone acetate/ethinyl estradiolNorethindrone/Ethinyl Estradiol

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 estradiolone tablet per day	Drug	study drug

Primary outcome

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,
Time frame: 13 cycles, 28 days each (1 year)
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population
Time frame: 13 Cycles, 28 days each (1 year)

15 secondary outcomes

Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population
Time frame: 2 Cycles, 28 days each (56 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population
Time frame: 6 cycles, 28 days each (168 days)
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population
Time frame: 13 cycles, 28 days each (1 year)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population
Time frame: 2 cycles, 28 days each (56 days)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population
Time frame: 6 cycles, 28 days each (168 days)
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population
Time frame: 13 cycles, 28 days each (1 year)
Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population
Time frame: 2 cycles, 28 days each (56 days)
Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population
Time frame: 6 cycles, 28 days each (168 days)
Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population
Time frame: 12 cycles, 28 days each (336 days)
Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population
Time frame: 2 cycles, 28 days each (56 days)
Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population
Time frame: 6 cycles, 28 days each (168 days)
Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population
Time frame: 13 cycles, 28 days each (1 year)
Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population
Time frame: 2 cycles, 28 days each (56 days)
Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population
Time frame: 6 cycles, 28 days each (168 days)
Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population
Time frame: 13 cycles, 28 days each (1 year)

Results and safety

Results posted to the registry on 22 Dec 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
Norethindrone/Ethinyl Estradiol	1,683	968

Primary outcome: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,

Time frame: 13 cycles, 28 days each (1 year). Number. Unit: Pregnancy Rate

Measure	Norethindrone/Ethinyl Estradiol n = 1266
Value	2.554

Population analysed: Modified Intent to Treat Population (MITT), Women Aged 18-35, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population

Primary outcome: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population

Time frame: 13 Cycles, 28 days each (1 year). Number. Unit: Pregnancy Rate

Measure	Norethindrone/Ethinyl Estradiol n = 1555
Value	2.167

Population analysed: MITT Population, All Subjects 18-45 years old, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Nov 2006 thru 27 Aug 2008 - 1 year, 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Norethindrone/Ethinyl Estradiol	15 of 1,660 (0.9%)	390 of 1,660 (23.5%)	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.
Derived from this study: PubMed 26410176Nakajima ST, Pappadakis J, Archer DF. Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive. Contraception. 2016 Jan;93(1):52-7. doi: 10.1016/j.contraception.2015.09.013. Epub 2015 Sep 26.
Derived from this study: PubMed 23921878Archer DF, Nakajima ST, Sawyer AT, Wentworth J, Trupin S, Koltun WD, Gilbert RD, Ellman H. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive. Obstet Gynecol. 2013 Sep;122(3):601-7. doi: 10.1097/AOG.0b013e3182a1741c.

Related trials for Contraception

Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
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Contraceptive Behavior, Self Administration
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
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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.

Herman Ellman, MD study director

Sponsor GmbH

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Norethindrone acetate/ethinyl estradiol in people with Contraception, run by Warner Chilcott at 66 sites 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 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 66 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 Dec 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?

Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, (time frame: 13 cycles, 28 days each (1 year)). The study lists 2 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 NCT00391807, which also lists 2 linked publications.

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.