Prevention of Pregnancy
Conditions
Keywords
Contraception
Brief summary
This is a 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 of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.
Interventions
DRUGNorethindrone Acetate/Ethinyl Estradiol 24 Days
One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
DRUGNorethindrone Acetate /Ethinyl Estradiol 21 Days
One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Women * Age 18-45 * At risk for pregnancy * History of regular cycles
Exclusion criteria
* Contraindications for use of hormonal contraception * Conditions which affect the absorption or metabolism of steroid hormones * BMI \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population | 5.6 months (6 - 28 day cycles) | Pearl Index = 1300 \* number of pregnancies/number of women-cycles of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population | 5.6 months (6 - 28 day cycles) | 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. |
Countries
United States
Participant flow
Recruitment details
32 investigational study sites recruited 938 women aged 18 - 45 years of age beginning Feb '04
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 24 Day NA/EE Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets | 751 |
| 21 Day NA/EE Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets | 187 |
| Total | 938 |
Baseline characteristics
| Characteristic | 24 Day NA/EE | Total | 21 Day NA/EE |
|---|---|---|---|
| Age, Customized 18-35 years | 579 Participants | 730 Participants | 151 Participants |
| Age, Customized > 35 years | 125 Participants | 154 Participants | 29 Participants |
| Age, Customized Age, Unknown | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 751 participants | 938 participants | 187 participants |
| Sex: Female, Male Female | 751 Participants | 938 Participants | 187 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 457 / 743 | 99 / 186 |
| serious Total, serious adverse events | 3 / 743 | 0 / 186 |
Outcome results
Primary
Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population
Pearl Index = 1300 \* number of pregnancies/number of women-cycles of treatment
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24 Day NA/EE | Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population | 1.823 Pearl Index |
| 21 Day NA/EE | Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population | 2.978 Pearl Index |
Secondary
Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
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.
Time frame: 5.6 months (6 - 28 day cycles)
Population: Modified Intent to Treat (MITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 24 Day NA/EE | Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population | 6.31 Days | Standard Deviation 9.16 |
| 21 Day NA/EE | Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population | 7.31 Days | Standard Deviation 10.51 |
p-value: 0.311Cochran-Mantel-Haenszel