Trial Outcomes & Findings for Study of Safety and Efficacy of an Oral Contraceptive (NCT NCT00477633)
NCT ID: NCT00477633
Last Updated: 2013-04-22
Results Overview
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1700 participants
Primary outcome timeframe
13 cycles (28 days each), approximately 364 days
Results posted on
2013-04-22
Participant Flow
Recruitment began 21 Jun 2007
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1700
|
|
Overall Study
COMPLETED
|
991
|
|
Overall Study
NOT COMPLETED
|
709
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Did not receive treatment
|
23
|
|
Overall Study
Adverse Event
|
143
|
|
Overall Study
Pregnancy
|
23
|
|
Overall Study
Lost to Follow-up
|
271
|
|
Overall Study
Withdrawal by Subject
|
149
|
|
Overall Study
Protocol Violation
|
25
|
|
Overall Study
Various (Moving, Enrollment closed)
|
75
|
Baseline Characteristics
Study of Safety and Efficacy of an Oral Contraceptive
Baseline characteristics by cohort
| Measure |
Norethindrone/Ethinyl Estradiol Tablets
n=1700 Participants
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
|
|---|---|
|
Age Continuous
|
28.8 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
|
Age, Customized
Between 18 and 35 years
|
1251 participants
n=99 Participants
|
|
Age, Customized
>35 years
|
319 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1700 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1700 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 13 cycles (28 days each), approximately 364 daysPopulation: MITT Population, Subjects Aged 18-35 years
Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol Tablets
n=1251 Participants
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
|
|---|---|
|
Pearl Index, 18-35 Years, MITT Population
|
1.903 Pearl Index
Interval 1.128 to 3.006
|
SECONDARY outcome
Timeframe: 12 cycles (28 days each), approximately 336 daysPopulation: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol Tablets
n=1570 Participants
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
|
|---|---|
|
Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
|
1.19 Days
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: 12 cycles (28 days each), approximately 336 daysPopulation: 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.
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol Tablets
n=1570 Participants
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
|
|---|---|
|
Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
|
3.52 Days
Standard Deviation 2.14
|
Adverse Events
Norethindrone/Ethinyl Estradiol Tablets
Serious events: 20 serious events
Other events: 1179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Norethindrone/Ethinyl Estradiol Tablets
n=1677 participants at risk
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
|
|---|---|
|
Infections and infestations
Mengitis, Viral
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Nervous system disorders
Headache
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Psychiatric disorders
Depression
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Psychiatric disorders
Suicidal Ideation
|
0.12%
2/1677 • Number of events 2 • 21 Jun 2007 thru 23 Jan 2009
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Psychiatric disorders
Anxiety
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Psychiatric disorders
Major Depression
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
General disorders
Chest Pain
|
0.12%
2/1677 • Number of events 2 • 21 Jun 2007 thru 23 Jan 2009
|
|
Surgical and medical procedures
Cholescystectomy
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Cardiac disorders
Angina pectoris
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Vascular disorders
Hypertension
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.12%
2/1677 • Number of events 2 • 21 Jun 2007 thru 23 Jan 2009
|
|
Infections and infestations
Staphylococcal Infection
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Diarrhea Hemorrhagic
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Colitis Ischemic
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
|
Investigations
Blood Pressure Increased
|
0.06%
1/1677 • Number of events 1 • 21 Jun 2007 thru 23 Jan 2009
|
Other adverse events
| Measure |
Norethindrone/Ethinyl Estradiol Tablets
n=1677 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
7.3%
122/1677 • Number of events 122 • 21 Jun 2007 thru 23 Jan 2009
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
7.2%
121/1677 • Number of events 121 • 21 Jun 2007 thru 23 Jan 2009
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.4%
91/1677 • Number of events 91 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Nausea
|
6.1%
102/1677 • Number of events 102 • 21 Jun 2007 thru 23 Jan 2009
|
|
Nervous system disorders
Headache
|
4.8%
80/1677 • Number of events 80 • 21 Jun 2007 thru 23 Jan 2009
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.8%
80/1677 • Number of events 80 • 21 Jun 2007 thru 23 Jan 2009
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.9%
66/1677 • Number of events 66 • 21 Jun 2007 thru 23 Jan 2009
|
|
Reproductive system and breast disorders
Vaginitis Bacterial
|
3.5%
58/1677 • Number of events 58 • 21 Jun 2007 thru 23 Jan 2009
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.2%
54/1677 • Number of events 54 • 21 Jun 2007 thru 23 Jan 2009
|
|
Reproductive system and breast disorders
Vulvovaginal Mycotic Infection
|
3.1%
52/1677 • Number of events 52 • 21 Jun 2007 thru 23 Jan 2009
|
|
Investigations
Laboratory Test Abnormal
|
2.9%
48/1677 • Number of events 48 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
46/1677 • Number of events 46 • 21 Jun 2007 thru 23 Jan 2009
|
|
Infections and infestations
Bronchitis
|
2.7%
46/1677 • Number of events 46 • 21 Jun 2007 thru 23 Jan 2009
|
|
Investigations
Weight Increased
|
2.3%
38/1677 • Number of events 38 • 21 Jun 2007 thru 23 Jan 2009
|
|
Investigations
Smear Cervix Abnormal
|
2.1%
36/1677 • Number of events 36 • 21 Jun 2007 thru 23 Jan 2009
|
|
Psychiatric disorders
Anxiety
|
2.1%
36/1677 • Number of events 36 • 21 Jun 2007 thru 23 Jan 2009
|
|
Infections and infestations
Fungal Infection
|
2.1%
35/1677 • Number of events 35 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
34/1677 • Number of events 34 • 21 Jun 2007 thru 23 Jan 2009
|
|
Gastrointestinal disorders
Gastroenteritis Viral
|
2.0%
34/1677 • Number of events 34 • 21 Jun 2007 thru 23 Jan 2009
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Phone: 973-442-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60