Healthy
Conditions
Keywords
Contraception
Brief summary
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel
Detailed description
This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study as stated in the study protocol are as follows: * To evaluate the efficacy of the study regimen among women who have sex 1-4 days a month and who are relying on the study regimen as their primary method of contraception * To evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia * To evaluate the acceptability of the regimen The study will enroll fertile women of reproductive age who have sex up to 6 days a month, are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives,have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months (each tablet contains 0.75 mg LNG to be used after every sex act).
Interventions
DRUGlevonorgestrel
oral contraceptive pills
Sponsors
FHI 360
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Each woman enrolled in the trial must meet the following inclusion criteria: * Competent to provide informed consent to participate in the trial and has done so. * At least the minimum age is 18 to 45 years old. * Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months. * At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following: * More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months * Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C * Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma * Sharing of illicit injection drug equipment ever in the past. * Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs). * Wants to avoid pregnancy for at least the next 6.5 months. * Willing to accept an uncertain risk of pregnancy during the study. * Gives correct answers to the informed consent quiz. * Willing and able to follow all study requirements.
Exclusion criteria
To be eligible for enrollment, a woman must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35) | 6.5 months | Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived |
| Participant Report of Adverse Events. | 6.5 months | Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Based on Bleeding Patterns Reported | 6.5 months | Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel |
Countries
Brazil, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Levonorgestrel 0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Levonorgestrel |
|---|---|
| Age Continuous | 32.4 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment Africa | 72 participants |
| Sex: Female, Male Female | 72 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 | 28 / 72 |
| serious Total, serious adverse events | 0 / 72 |
Outcome results
Primary
Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)
Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived
Time frame: 6.5 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levonorgestrel | Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35) | 22.4 pregnancies per 100 woman years |
Primary
Participant Report of Adverse Events.
Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken
Time frame: 6.5 months
Population: A total of 58 women documented use of product on coital diaries and are included in the User Population for primary safety analysis. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levonorgestrel | Participant Report of Adverse Events. | 45 adverse events |
Secondary
Acceptability Based on Bleeding Patterns Reported
Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel
Time frame: 6.5 months
Population: A total of 56 women reported on their bleeding patterns, of these, 43 found it acceptable. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levonorgestrel | Acceptability Based on Bleeding Patterns Reported | 43 participants |