Contraception
Conditions
Keywords
Contraception
Brief summary
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.
Interventions
1 tablet per day
Sponsors
Warner Chilcott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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 |
|---|---|---|
| Pearl Index, 18-35 Years, MITT Population | 13 cycles (28 days each), approximately 364 days | Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | 12 cycles (28 days each), approximately 336 days | — |
| Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | 12 cycles (28 days each), approximately 336 days | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment began 21 Jun 2007
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,700 |
| Total | 1,700 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 143 |
| Overall Study | Did not receive treatment | 23 |
| Overall Study | Lost to Follow-up | 271 |
| Overall Study | Pregnancy | 23 |
| Overall Study | Protocol Violation | 25 |
| Overall Study | Various (Moving, Enrollment closed) | 75 |
| Overall Study | Withdrawal by Subject | 149 |
Baseline characteristics
| Characteristic | Norethindrone/Ethinyl Estradiol Tablets |
|---|---|
| Age Continuous | 28.8 years STANDARD_DEVIATION 7.1 |
| Age, Customized >35 years | 319 participants |
| Age, Customized Between 18 and 35 years | 1251 participants |
| Region of Enrollment United States | 1700 participants |
| Sex: Female, Male Female | 1700 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,179 / 1,677 |
| serious Total, serious adverse events | 20 / 1,677 |
Outcome results
Primary
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
Population: MITT Population, Subjects Aged 18-35 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Norethindrone/Ethinyl Estradiol Tablets | Pearl Index, 18-35 Years, MITT Population | 1.903 Pearl Index |
Secondary
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
Population: MITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norethindrone/Ethinyl Estradiol Tablets | Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | 3.52 Days | Standard Deviation 2.14 |
Secondary
Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
Time frame: 12 cycles (28 days each), approximately 336 days
Population: MITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norethindrone/Ethinyl Estradiol Tablets | Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population | 1.19 Days | Standard Deviation 1.79 |