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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study drug | Experimental | Norethindrone/Ethinyl Estradiol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethindrone acetate/ethinyl estradiol | Drug | one tablet per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, | 13 cycles, 28 days each (1 year) | |
| Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population | 13 Cycles, 28 days each (1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population | MITT Population | 2 Cycles, 28 days each (56 days) |
| Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman, MD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85014 | United States | ||
| Warner Chilcott Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26410176 | Derived | 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. | |
| 23921878 | Derived | 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. |
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Recruitment period 01 Nov '06 thru 24 Aug '08
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| ID | Title | Description |
|---|---|---|
| FG000 | Norethindrone/Ethinyl Estradiol | 1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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MITT Population
| 6 cycles, 28 days each (168 days) |
| Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population | MITT Population | 13 cycles, 28 days each (1 year) |
| Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) |
| Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) |
| Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population | 13 cycles, 28 days each (1 year) |
| Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) |
| Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) |
| Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population | 12 cycles, 28 days each (336 days) |
| Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) |
| Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) |
| Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population | 13 cycles, 28 days each (1 year) |
| Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) |
| Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) |
| Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population | 13 cycles, 28 days each (1 year) |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85032 | United States |
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85050 | United States |
| Warner Chilcott Investigational Site | Tempe | Arizona | 85283 | United States |
| Warner Chilcott Investigational Site | Tempe | Arizona | United States |
| Warner Chilcott Investigational Site | Tucson | Arizona | 85712 | United States |
| Warner Chilcott Investigational Site | Carmichael | California | 95608 | United States |
| Warner Chilcott Investigational Site | San Diego | California | 92103 | United States |
| Warner Chilcott Investigational Site | San Diego | California | 92108 | United States |
| Warner Chilcott Investigational Site | Denver | Colorado | 80218 | United States |
| Warner Chilcott Investigational Site | Boynton Beach | Florida | 33437 | United States |
| Warner Chilcott Investigational Site | Clearwater | Florida | 33759 | United States |
| Warner Chilcott Investigational Site | Jacksonville | Florida | 32207 | United States |
| Warner Chilcott Investigational Site | Leesburg | Florida | 34748 | United States |
| Warner Chilcott Investigational Site | Longwood | Florida | 32779 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33143 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33186 | United States |
| Warner Chilcott Investigational Site | New Port Richey | Florida | 34652 | United States |
| Warner Chilcott Investigational Site | Pembroke Pines | Florida | United States |
| Warner Chilcott Investigational Site | Plantation | Florida | 33324 | United States |
| Warner Chilcott Investigational Site | St. Petersburg | Florida | 33709 | United States |
| Warner Chilcott Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Warner Chilcott Investigational Site | West Palm Beach | Florida | United States |
| Warner Chilcott Investigational Site | Roswell | Georgia | 30075 | United States |
| Warner Chilcott Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| Warner Chilcott Investigational Site | Champaign | Illinois | 61820 | United States |
| Warner Chilcott Investigational Site | Peoria | Illinois | 61615 | United States |
| Warner Chilcott Investigational Site | Indianapolis | Indiana | United States |
| Warner Chilcott Investigational Site | Wichita | Kansas | United States |
| Warner Chilcott Investigational Site | Lexington | Kentucky | 40509 | United States |
| Warner Chilcott Investigational Site | Louisville | Kentucky | 40202 | United States |
| Warner Chilcott Investigational Site | Louisville | Kentucky | 40291 | United States |
| Warner Chilcott Investigational Site | Berlin | New Jersey | 08009 | United States |
| Warner Chilcott Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Warner Chilcott Investigational Site | Moorestown | New Jersey | 08057 | United States |
| Warner Chilcott Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Warner Chilcott Investigational Site | Cary | North Carolina | United States |
| Warner Chilcott Investigational Site | New Bern | North Carolina | 28562 | United States |
| Warner Chilcott Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | United States |
| Warner Chilcott Investigational Site | Cleveland | Ohio | 44122 | United States |
| Warner Chilcott Investigational Site | Columbus | Ohio | 43213 | United States |
| Warner Chilcott Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Warner Chilcott Investigational Site | Portland | Oregon | 97210 | United States |
| Warner Chilcott Investigational Site | Portland | Oregon | 97239 | United States |
| Warner Chilcott Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Warner Chilcott Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Warner Chilcott Investigational Site | Pottstown | Pennsylvania | 19464-3224 | United States |
| Warner Chilcott Investigational Site | Charleston | South Carolina | 29401 | United States |
| Warner Chilcott Investigational Site | Columbia | South Carolina | 29201 | United States |
| Warner Chilcott Investigational Site | Greenville | South Carolina | 29615 | United States |
| Warner Chilcott Investigational Site | Dallas | Texas | United States |
| Warner Chilcott Investigational Site | Houston | Texas | 77030 | United States |
| Warner Chilcott Investigational Site | San Antonio | Texas | 78229 | United States |
| Warner Chilcott Investigational Site | Magna | Utah | 84044 | United States |
| Warner Chilcott Investigational Site | Salt Lake City | Utah | 84017 | United States |
| Warner Chilcott Investigational Site | Salt Lake City | Utah | 84109 | United States |
| Warner Chilcott Investigational Site | Sandy City | Utah | 84070 | United States |
| Warner Chilcott Investigational Site | Norfolk | Virginia | 23507-1627 | United States |
| Warner Chilcott Investigational Site | Richmond | Virginia | 23233 | United States |
| Warner Chilcott Investigational Site | Virginia Beach | Virginia | 23456 | United States |
| Warner Chilcott Investigational Site | Seattle | Washington | 98105 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99207 | United States |
| Warner Chilcott Investigational Site | Tacoma | Washington | 98405 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Norethindrone/Ethinyl Estradiol | 1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | MITT (Modified Intent to Treat) Population | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Age, Customized | MITT Population | Number | participants |
| ||||||||||||||||||||||
| Gender | MITT Population | Number | participants |
| ||||||||||||||||||||||
| Region of Enrollment | MITT Population | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, | 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 | Posted | Number | Pregnancy Rate | 13 cycles, 28 days each (1 year) | Pregnancies | Participants |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population | MITT Population | MITT Population | Posted | Mean | Standard Deviation | Bleeding/Spotting Days | 2 Cycles, 28 days each (56 days) |
|
| ||||||||||||||||||||||||||||
| Primary | Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population | 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 | Posted | Number | Pregnancy Rate | 13 Cycles, 28 days each (1 year) | Pregnancies | Participants |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population | MITT Population | MITT Population | Posted | Mean | Standard Deviation | Bleeding/Spotting Days | 6 cycles, 28 days each (168 days) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population | MITT Population | MITT Population | Posted | Mean | Standard Deviation | Bleeding/Spotting Days | 13 cycles, 28 days each (1 year) |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population | MITT Population | Posted | Number | Percentage of Participants | 2 cycles, 28 days each (56 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population | MITT Population | Posted | Number | Percentage of Participants | 6 cycles, 28 days each (168 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population | MITT Population | Posted | Number | Percentage of Participants | 13 cycles, 28 days each (1 year) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population | MITT Population | Posted | Median | Standard Deviation | Days | 2 cycles, 28 days each (56 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population | MITT Population | Posted | Median | Standard Deviation | Days | 6 cycles, 28 days each (168 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population | MITT Population | Posted | Median | Standard Deviation | Days | 12 cycles, 28 days each (336 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population | MITT Population | Posted | Mean | Standard Deviation | Days | 2 cycles, 28 days each (56 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population | MITT Population | Posted | Mean | Standard Deviation | Days | 6 cycles, 28 days each (168 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population | MITT Population | Posted | Mean | Standard Deviation | Days | 13 cycles, 28 days each (1 year) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population | MITT Population | Posted | Number | Percentage of Participants | 2 cycles, 28 days each (56 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population | MITT Population | Posted | Number | Percentage of Participants | 6 cycles, 28 days each (168 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population | MITT Population | Posted | Number | Percentage of Participants | 13 cycles, 28 days each (1 year) |
|
|
1 Nov 2006 thru 27 Aug 2008 - 1 year, 9 months
1683 Subjects Randomized but 23 subjects did not take study medication therefore 1660 subjects evaluated for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Norethindrone/Ethinyl Estradiol | 1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days | 15 | 1,660 | 390 | 1,660 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Hyperemesis Gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA (11.0) | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Venous Thrombosis (Ovarian) | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Food Poisoning | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Transverse Sinus Thrombosis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Partial Hysterectomy with Bladder Sling (Elective Therapeutic Procedure) | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D000077563 | Norethindrone Acetate |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009640 | Norethindrone |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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