A Phase 3 interventional study of Norethindrone/ethinyl estradiol in Contraception, sponsored by Warner Chilcott. Completed at 63 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-22.
Sponsored by Warner Chilcott (part of AbbVie) · Phase 3, Interventional, and Prevention
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.
Warner Chilcott is the lead sponsor of 58 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted before Warner Chilcott became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
1 tablet per day
Drug: Norethindrone/ethinyl estradiol
Drug pages: Norethindrone · Ethinyl Estradiol
1 tablet per day
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
Time frame: 13 cycles (28 days each), approximately 364 days
Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Time frame: 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.
Time frame: 12 cycles (28 days each), approximately 336 days
Recruitment began 21 Jun 2007
| Milestone | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Started | 1700 |
| Completed | 991 |
| Not completed | 709 |
| Withdrew: Did not receive treatment | 23 |
| Withdrew: Adverse event | 143 |
| Withdrew: Pregnancy | 23 |
| Withdrew: Lost to follow-up | 271 |
| Withdrew: Withdrawal by subject | 149 |
| Withdrew: Protocol violation | 25 |
| Withdrew: Various (moving, enrollment closed) | 75 |
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
| Pearl Index | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Pearl Index, 18-35 Years, MITT Population | 1.903 (1.128 to 3.006) |
| Days | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | 1.19 ± 1.79 |
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.
| Days | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | 3.52 ± 2.14 |
Collected over 21 Jun 2007 thru 23 Jan 2009. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Norethindrone/Ethinyl Estradiol Tablets | — | 20/1,677 (1.2%) | 1,179/1,677 (70.3%) |
| Event | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Suicidal IdeationPsychiatric disorders | 2/1677 |
| Chest PainGeneral disorders | 2/1677 |
| Abdominal PainGastrointestinal disorders | 2/1677 |
| Mengitis, ViralInfections and infestations | 1/1677 |
| HeadacheNervous system disorders | 1/1677 |
| DepressionPsychiatric disorders | 1/1677 |
| Flank PainMusculoskeletal and connective tissue disorders | 1/1677 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/1677 |
| Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 1/1677 |
| AnxietyPsychiatric disorders | 1/1677 |
| Event | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 122/1677 |
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 121/1677 |
| NauseaGastrointestinal disorders | 102/1677 |
| SinusitisRespiratory, thoracic and mediastinal disorders | 91/1677 |
| HeadacheNervous system disorders | 80/1677 |
| Urinary Tract InfectionRenal and urinary disorders | 80/1677 |
| DysmenorrhoeaReproductive system and breast disorders | 66/1677 |
| Vaginitis BacterialReproductive system and breast disorders | 58/1677 |
| AcneSkin and subcutaneous tissue disorders | 54/1677 |
| Vulvovaginal Mycotic InfectionReproductive system and breast disorders | 52/1677 |
| Age Continuous(years) | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Mean | 28.8 ± 7.1 |
| Age, Customized(participants) | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Between 18 and 35 years | 1251 |
| >35 years | 319 |
| Sex: Female, Male(Participants) | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Female | 1700 |
| Male | 0 |
| Region of Enrollment(participants) | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| United States | 1700 |
The record gives a start of Jun 2007, a primary completion of Jan 2009 and a completion of Feb 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2011, 2 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Norethindrone · Ethinyl Estradiol