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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 NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 Day NA/EE | Experimental | Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle |
|
| 21 Day NA/EE | Active Comparator | Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethindrone Acetate/Ethinyl Estradiol 24 Days | Drug | One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5.6 months (6 - 28 day cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 | Birmingham | Alabama | 35233 | United States | ||
| Warner Chilcott Investigational Site |
MITT Population defined as subset of All Treated Subjects who were evaluated for pregnancy, either positive or negative, at least once after beginning the study medication. Completed subjects - subset of MITT subjects completing at least 161 days of treatment based on returned drug or diary.
32 investigational study sites recruited 938 women aged 18 - 45 years of age beginning Feb '04
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| ID | Title | Description |
|---|---|---|
| FG000 | 24 Day NA/EE | Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets |
| FG001 | 21 Day NA/EE | Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Norethindrone Acetate /Ethinyl Estradiol 21 Days | Drug | One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets |
|
|
| 5.6 months (6 - 28 day cycles) |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85031 | United States |
| Warner Chilcott Investigational Site | Chico | California | 95929 | United States |
| Warner Chilcott Investigational Site | Los Angeles | California | 90033 | 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 | 80202 | United States |
| Warner Chilcott Investigational Site | Boynton Beach | Florida | 33437 | United States |
| Warner Chilcott Investigational Site | Jacksonville | Florida | 32207 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33186 | United States |
| Warner Chilcott Investigational Site | Palm Harbor | Florida | 34684 | United States |
| Warner Chilcott Investigational Site | Venice | Florida | 34285 | United States |
| Warner Chilcott Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Warner Chilcott Investigational Site | Decatur | Georgia | 30033 | United States |
| Warner Chilcott Investigational Site | Decatur | Georgia | 30034 | United States |
| Warner Chilcott Investigational Site | Powder Springs | Georgia | 30127 | United States |
| Warner Chilcott Investigational Site | Roswell | Georgia | 30075 | United States |
| Warner Chilcott Investigational Site | Savannah | Georgia | 31405 | United States |
| Warner Chilcott Investigational Site | Louisville | Kentucky | 40202 | United States |
| Warner Chilcott Investigational Site | Kansas City | Missouri | 64112 | United States |
| Warner Chilcott Investigational Site | St Louis | Missouri | 63117 | United States |
| Warner Chilcott Investigational Site | New Bern | North Carolina | 28562 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Warner Chilcott Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| Warner Chilcott Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Warner Chilcott Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Warner Chilcott Investigational Site | Charleston | South Carolina | 29425 | United States |
| Warner Chilcott Investigational Site | Greenville | South Carolina | 29605 | United States |
| Warner Chilcott Investigational Site | Sandy City | Utah | 84070 | United States |
| Warner Chilcott Investigational Site | Norfolk | Virginia | 23507 | 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 |
| MITT Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 24 Day NA/EE | Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets |
| BG001 | 21 Day NA/EE | Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | MITT (Modified Intent to Treat) Population | Number | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | 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) for Women 18 to 45 Years Old, MITT Population | Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment | Modified intention to treat (MITT) subset of all treat subjects - evaluated for pregnancy at least once after beginning study medication. | Posted | Number | Pearl Index | 5.6 months (6 - 28 day cycles) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Modified Intent to Treat (MITT) | Posted | Mean | Standard Deviation | Days | 5.6 months (6 - 28 day cycles) |
|
|
10 months, between 5 Feb 2004 and 30 Nov 2004
Nine randomized subjects returned all study medication unused resulting in the following treated subjects: 743 in 24 day NA/EE group and 186 in 21 day NA/EE group. Adverse Events were collected on this population.
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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 | 24 Day NA/EE | Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets | 3 | 743 | 457 | 743 | ||
| EG001 | 21 Day NA/EE | Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets | 0 | 186 | 99 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partial Thyroidectomy | Surgical and medical procedures | MedDRA 6.0 | Systematic Assessment |
| |
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.0 | Systematic Assessment |
| |
| Back Injury | Injury, poisoning and procedural complications | MedDRA 6.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Vaginal Candidiasis | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
| |
| Gastroenteritis, Viral | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Breast Tenderness | Reproductive system and breast disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Metorrhagia | Reproductive system and breast disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Smear Cervix Abnormal | Investigations | MedDRA 6.0 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA 6.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Mood Swings | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6.0 | 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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| Title | Measurements |
|---|---|
|
| > 35 years |
|
| Male |
|
|
|