Trial Outcomes & Findings for Study of Safety and Efficacy of an Oral Contraceptive (NCT NCT00391807)
NCT ID: NCT00391807
Last Updated: 2013-04-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1683 participants
Primary outcome timeframe
13 cycles, 28 days each (1 year)
Results posted on
2013-04-22
Participant Flow
Recruitment period 01 Nov '06 thru 24 Aug '08
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1683
|
|
Overall Study
COMPLETED
|
968
|
|
Overall Study
NOT COMPLETED
|
715
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Did not receive study medication
|
23
|
|
Overall Study
Adverse Event
|
177
|
|
Overall Study
Pregnancy
|
25
|
|
Overall Study
Lost to Follow-up
|
227
|
|
Overall Study
Withdrawal by Subject
|
147
|
|
Overall Study
Protocol Violation
|
20
|
|
Overall Study
Various
|
96
|
Baseline Characteristics
Study of Safety and Efficacy of an Oral Contraceptive
Baseline characteristics by cohort
| Measure |
Norethindrone/Ethinyl Estradiol
n=1683 Participants
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
|
|---|---|
|
Age Continuous
|
28.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Age, Customized
18-35 years
|
1295 participants
n=5 Participants
|
|
Age, Customized
>35 years
|
287 participants
n=5 Participants
|
|
Gender
Female
|
1582 participants
n=5 Participants
|
|
Gender
Male
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1582 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 cycles, 28 days each (1 year)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
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=24 Pregnancies
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
|
|---|---|
|
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,
|
2.554 Pregnancy Rate
|
PRIMARY outcome
Timeframe: 13 Cycles, 28 days each (1 year)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
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=26 Pregnancies
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
|
|---|---|
|
Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population
|
2.167 Pregnancy Rate
|
SECONDARY outcome
Timeframe: 2 Cycles, 28 days each (56 days)Population: MITT Population
MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population
|
3.21 Bleeding/Spotting Days
Standard Deviation 4.15
|
SECONDARY outcome
Timeframe: 6 cycles, 28 days each (168 days)Population: MITT Population
MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population
|
2.00 Bleeding/Spotting Days
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: 13 cycles, 28 days each (1 year)Population: MITT Population
MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population
|
1.81 Bleeding/Spotting Days
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: 2 cycles, 28 days each (56 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population
|
34.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 cycles, 28 days each (168 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population
|
25.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 13 cycles, 28 days each (1 year)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population
|
22.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 2 cycles, 28 days each (56 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population
|
3.93 Days
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: 6 cycles, 28 days each (168 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population
|
3.99 Days
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: 12 cycles, 28 days each (336 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population
|
3.85 Days
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 2 cycles, 28 days each (56 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population
|
4.57 Days
Standard Deviation 4.94
|
SECONDARY outcome
Timeframe: 6 cycles, 28 days each (168 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population
|
3.00 Days
Standard Deviation 3.73
|
SECONDARY outcome
Timeframe: 13 cycles, 28 days each (1 year)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population
|
3.36 Days
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: 2 cycles, 28 days each (56 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population
|
30.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 cycles, 28 days each (168 days)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population
|
42.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 13 cycles, 28 days each (1 year)Population: MITT Population
Outcome measures
| Measure |
Norethindrone/Ethinyl Estradiol
n=1582 Participants
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
|
|---|---|
|
Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population
|
49.1 Percentage of Participants
|
Adverse Events
Norethindrone/Ethinyl Estradiol
Serious events: 15 serious events
Other events: 390 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Norethindrone/Ethinyl Estradiol
n=1660 participants at risk
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
|
|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Infections and infestations
Appendicitis
|
0.18%
3/1660 • Number of events 3 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis Gravidarum
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Vascular disorders
Venous Thrombosis (Ovarian)
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Nervous system disorders
Transverse Sinus Thrombosis
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Infections and infestations
Pharyngitis
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Infections and infestations
Sepsis
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Partial Hysterectomy with Bladder Sling (Elective Therapeutic Procedure)
|
0.06%
1/1660 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.06%
1/1660 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Norethindrone/Ethinyl Estradiol
n=1660 participants at risk
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
|
|---|---|
|
Nervous system disorders
Headache
|
7.0%
116/1660 • Number of events 116 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
6.2%
103/1660 • Number of events 103 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.2%
86/1660 • Number of events 86 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.1%
85/1660 • Number of events 85 • 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.
|
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