Trial Outcomes & Findings for Study of Safety and Efficacy of an Oral Contraceptive (NCT NCT00932321)
NCT ID: NCT00932321
Last Updated: 2013-04-22
Results Overview
Pearl Index = 1300 \* number of pregnancies/number of women-cycles of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
938 participants
Primary outcome timeframe
5.6 months (6 - 28 day cycles)
Results posted on
2013-04-22
Participant Flow
32 investigational study sites recruited 938 women aged 18 - 45 years of age beginning Feb '04
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.
Participant milestones
| Measure |
24 Day NA/EE
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
|
21 Day NA/EE
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
751
|
187
|
|
Overall Study
MITT Population
|
705
|
181
|
|
Overall Study
COMPLETED
|
580
|
141
|
|
Overall Study
NOT COMPLETED
|
171
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Safety and Efficacy of an Oral Contraceptive
Baseline characteristics by cohort
| Measure |
24 Day NA/EE
n=751 Participants
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
|
21 Day NA/EE
n=187 Participants
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
|
Total
n=938 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
18-35 years
|
579 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
730 Participants
n=5 Participants
|
|
Age, Customized
> 35 years
|
125 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
751 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
938 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
751 participants
n=5 Participants
|
187 participants
n=7 Participants
|
938 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5.6 months (6 - 28 day cycles)Population: Modified intention to treat (MITT) subset of all treat subjects - evaluated for pregnancy at least once after beginning study medication.
Pearl Index = 1300 \* number of pregnancies/number of women-cycles of treatment
Outcome measures
| Measure |
24 Day NA/EE
n=705 Participants
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
|
21 Day NA/EE
n=181 Participants
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
|
|---|---|---|
|
Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population
|
1.823 Pearl Index
|
2.978 Pearl Index
|
SECONDARY outcome
Timeframe: 5.6 months (6 - 28 day cycles)Population: Modified Intent to Treat (MITT)
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.
Outcome measures
| Measure |
24 Day NA/EE
n=705 Participants
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
|
21 Day NA/EE
n=181 Participants
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
|
|---|---|---|
|
Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
|
6.31 Days
Standard Deviation 9.16
|
7.31 Days
Standard Deviation 10.51
|
Adverse Events
24 Day NA/EE
Serious events: 3 serious events
Other events: 457 other events
Deaths: 0 deaths
21 Day NA/EE
Serious events: 0 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
24 Day NA/EE
n=743 participants at risk
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
|
21 Day NA/EE
n=186 participants at risk
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
|
|---|---|---|
|
Surgical and medical procedures
Partial Thyroidectomy
|
0.13%
1/743 • Number of events 1 • 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.
|
0.00%
0/186 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.13%
1/743 • Number of events 1 • 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.
|
0.00%
0/186 • 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.
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.13%
1/743 • Number of events 1 • 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.
|
0.00%
0/186 • 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.
|
Other adverse events
| Measure |
24 Day NA/EE
n=743 participants at risk
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
|
21 Day NA/EE
n=186 participants at risk
Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.3%
47/743 • 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.
|
7.0%
13/186 • 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.
|
|
Infections and infestations
Vaginal Candidiasis
|
6.1%
45/743 • 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.
|
5.4%
10/186 • 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.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.1%
38/743 • 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.
|
4.8%
9/186 • 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.
|
|
Infections and infestations
Sinusitis
|
3.1%
23/743 • 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.
|
2.2%
4/186 • 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.
|
|
Infections and infestations
Vaginitis bacterial
|
3.1%
23/743 • 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.
|
1.6%
3/186 • 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.
|
|
Infections and infestations
Urinary Tract Infection
|
2.4%
18/743 • 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.
|
2.7%
5/186 • 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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.5%
11/743 • 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.
|
1.1%
2/186 • 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.
|
|
Infections and infestations
Gastroenteritis, Viral
|
1.1%
8/743 • 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.
|
2.2%
4/186 • 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.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
34/743 • 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.
|
3.2%
6/186 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
14/743 • 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.
|
0.54%
1/186 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
9/743 • 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.
|
0.54%
1/186 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
8/743 • 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.
|
1.1%
2/186 • 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.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
4.4%
33/743 • 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.
|
2.7%
5/186 • 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.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
3.4%
25/743 • 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.
|
1.1%
2/186 • 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.
|
|
Reproductive system and breast disorders
Metorrhagia
|
1.9%
14/743 • 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.
|
1.1%
2/186 • 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.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
1.3%
10/743 • 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.
|
1.1%
2/186 • 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.
|
|
Investigations
Smear Cervix Abnormal
|
3.1%
23/743 • 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.
|
3.2%
6/186 • 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.
|
|
Investigations
Weight Increased
|
2.0%
15/743 • 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.
|
1.6%
3/186 • 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.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.7%
20/743 • 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.
|
2.7%
5/186 • 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.
|
|
Psychiatric disorders
Mood Swings
|
2.2%
16/743 • 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.
|
2.7%
5/186 • 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.
|
|
Psychiatric disorders
Depression
|
1.1%
8/743 • 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.
|
2.2%
4/186 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.94%
7/743 • 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.
|
1.6%
3/186 • 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.
|
|
General disorders
Fatigue
|
1.1%
8/743 • 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.
|
1.1%
2/186 • 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.
|
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