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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 |
|---|---|---|---|
| Norethindrone/ethinyl estradiol | Experimental | 1 tablet per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethindrone/ethinyl estradiol | Drug | 1 tablet per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pearl Index, 18-35 Years, MITT Population | Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment | 13 cycles (28 days each), approximately 364 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | 12 cycles (28 days each), approximately 336 days | |
| Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain "mean median duration" of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Chandler | Arizona | 85224 | United States | ||
| Warner Chilcott Investigational Site |
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Recruitment began 21 Jun 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Norethindrone/Ethinyl Estradiol Tablets | 1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 12 cycles (28 days each), approximately 336 days |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85037 | United States |
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85050 | United States |
| Warner Chilcott Investigational Site | Tempe | Arizona | 85282 | United States |
| Warner Chilcott Investigational Site | Tucson | Arizona | 85712 | 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 | Vista | California | 92083 | United States |
| Warner Chilcott Investigational Site | Castle Rock | Colorado | 80108 | United States |
| Warner Chilcott Investigational Site | Denver | Colorado | 80218 | United States |
| Warner Chilcott Investigational Site | Lakewood | Colorado | 80228 | United States |
| Warner Chilcott Investigational Site | Boynton Beach | Florida | 33472 | United States |
| Warner Chilcott Investigational Site | Brooksville | Florida | 34613 | United States |
| Warner Chilcott Investigational Site | Clearwater | Florida | 33759 | United States |
| Warner Chilcott Investigational Site | Gainesville | Florida | 32607 | United States |
| Warner Chilcott Investigational Site | Jacksonville | Florida | 32207 | United States |
| Warner Chilcott Investigational Site | Leesburg | Florida | 34748 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33143 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33186 | United States |
| Warner Chilcott Investigational Site | Pembroke Pines | Florida | 33021 | 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 | 33409 | United States |
| Warner Chilcott Investigational Site | Decatur | Georgia | 30034 | 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 | 46250 | United States |
| Warner Chilcott Investigational Site | Arkansas City | Kansas | 67005 | United States |
| Warner Chilcott Investigational Site | Wichita | Kansas | 67207 | United States |
| Warner Chilcott Investigational Site | Lexington | Kentucky | 40509 | United States |
| Warner Chilcott Investigational Site | Louisville | Kentucky | 40291 | United States |
| Warner Chilcott Investigational Site | Amite | Louisiana | 70422 | United States |
| Warner Chilcott Investigational Site | Marrero | Louisiana | 70072 | United States |
| Warner Chilcott Investigational Site | Chaska | Minnesota | 55318 | United States |
| Warner Chilcott Investigational Site | Berlin | New Jersey | 08009 | United States |
| Warner Chilcott Investigational Site | Edison | New Jersey | 08817 | United States |
| Warner Chilcott Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Warner Chilcott Investigational Site | Moorestown | New Jersey | 08051 | United States |
| Warner Chilcott Investigational Site | New York | New York | 10016 | United States |
| Warner Chilcott Investigational Site | Cary | North Carolina | 27511 | United States |
| Warner Chilcott Investigational Site | New Bern | North Carolina | 28562 | United States |
| Warner Chilcott Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Warner Chilcott Investigational Site | Cleveland | Ohio | 44122 | United States |
| Warner Chilcott Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Warner Chilcott Investigational Site | Medford | Oregon | 97504 | 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 | Columbia | South Carolina | 29201 | United States |
| Warner Chilcott Investigational Site | Austin | Texas | 78748 | United States |
| Warner Chilcott Investigational Site | Austin | Texas | 78759 | United States |
| Warner Chilcott Investigational Site | Dallas | Texas | 75234 | 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 | 84109 | United States |
| Warner Chilcott Investigational Site | Salt Lake City | Utah | 84121 | United States |
| Warner Chilcott Investigational Site | West Valley City | Utah | 84120 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Norethindrone/Ethinyl Estradiol Tablets | 1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | MITT Population | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Age, Customized | MITT 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 | Pearl Index, 18-35 Years, MITT Population | Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment | MITT Population, Subjects Aged 18-35 years | Posted | Number | 95% Confidence Interval | Pearl Index | 13 cycles (28 days each), approximately 364 days |
|
|
| |||||||||||||||||||||||||
| Secondary | Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | MITT Population | Posted | Mean | Standard Deviation | Days | 12 cycles (28 days each), approximately 336 days |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain "mean median duration" of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated. | MITT Population | Posted | Mean | Standard Deviation | Days | 12 cycles (28 days each), approximately 336 days |
|
|
21 Jun 2007 thru 23 Jan 2009
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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 Tablets | 1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo | 20 | 1,677 | 1,179 | 1,677 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mengitis, Viral | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholescystectomy | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhea Hemorrhagic | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Colitis Ischemic | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vaginitis Bacterial | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Vulvovaginal Mycotic Infection | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Laboratory Test Abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Smear Cervix Abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fungal Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastroenteritis Viral | Gastrointestinal 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 |
|---|---|
| C484525 | ovcon 35 |
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