None listed
Conditions
Interventions
Lunelle Type of group
Lunelle SC (0.5 ml of AMP 20 mg in combination with E2C 5 mg) will be administered subcutaneously every 28 ± 2 days without exceeding 33 days, during 12 months
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Sexually active women between the ages of 18 and 49 at risk of becoming pregnant and who want contraception. • Must be willing to rely exclusively on Lunelle SC for contraception for at least 1 year. • Subjects who use hormonal birth control must undergo the following wash program; During this period they must use a barrier contraceptive method (not an IUD) or not be sexually active • Analysis of negative pregnancy in urine. • Must have a documented history of menstruating on a regular basis (cycle length: 25 to 35 days) during the 3 months prior to entering the study. This includes patients who are in postpartum and post-abortion period. • Show willingness to enter the study and comply with the specific procedures of the same. • Show willingness and be able to return at prescribed intervals for follow-up visits. • Evidence of a signed and dated informed consent document indicating that the patient (or her legally acceptable representative) was informed of all relevant aspects of the trial.
Exclusion criteria
Exclusion criteria: • Concomitant use of aminoglutethimide, carbamazepine, rifampicin, griseofulvin, hydantoins, barbiturates, oxazepam, GnRH agonists, St. John´s wort, or antibiotics of the ampicillin and tetracycline classes. • Cervical cytology: Any abnormality in the epithelial cells as reported in the Bethesda System, with the exception of reactive and reparative changes, such as: atypical squamous cells of undetermined significance (ASCUS) in the last 6 months prior to entering the study. • History of cancer, suspected, current or past, with the exception of the carcinoma insitu of the neck of the uterus treated, with subsequent normal pap smears for 12 months, and basal cell cancer of the skin. • Presumed / undiagnosed pelvic disease. • Use of IUDs or hormonal birth control methods other than the study medication during the treatment period. • Current breastfeeding or breastfeeding within the last three months. • Selection mammography results that suggest a malignant disease or require a follow-up of 6 months. Mammograms (within the last 12 months) are only required for subjects over 40 years of age. • Women or their partners with a diagnosis of known infertility. • Known or suspected pregnancy, or desire to achieve pregnancy during the study. • Past or present thromboembolic disease, with the exception of superficial thrombophlebitis. • Coronary artery disease or active cerebral vascular disease or history of having suffered such a disease. • Unexplained abnormal genital bleeding. • Antecedents (within the last five years) of alcohol abuse (more than 2 to 3 drinks per day) or other abuse of Medicines. • Cholestatic jaundice of pregnancy, or a history of jaundice with previous use of hormonal contraception including severe pruritus of pregnancy. • Current hypertension confirmed: defined as systolic blood pressure> 160 mmHg or diastolic> 90 mmHg. Stable hypertension is authorized under antihypertensive medication during the previous 6 months. • Active pathology or history of clinically significant liver or kidney pathology. (Hepatopathology is defined as a level of AST / SGOT, ALT / SGPT, or GGPT 2.5 times the upper normal limit, and a total bilirubin level> 1.5 mg / dl, the renal is defined as a level of creatinine> 1.5 mg / dl). • Hypersensitivity to study medications, or subjects in whom estrogen and / or progestin are contraindicated. • Any subject unable to understand the necessary instructions, or who is reasonably expected to not complete the study. • Concurrent use of other medications under investigation or their use in the previous 30 days. • Previous participation in this study. • Diabetes mellitus with vascular compromise. • Headaches with focal neurological symptoms. • Vascular cardiac pathology with complications. • Women over 35 years old smokers (> 15 cigarettes / day). • Other chronic medical condition, severe acute, or psychiatric, laboratory abnormality or consumption of another Medicine that may increase the risk associated with participation in the study or with the administration of study Medicine, or that may interfere with the interpretation of the results of the study, and that, according to the investigator´s criteria, it makes the subject inappropriate to enter the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:At each visit during the treatment period, a pregnancy analysis will be carried out for all patients. Measure:Cumulative pregnancy rate over the 12 months Timepoints:12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The Journal of Bleeding obtained from the information that appears in the menstrual journals will be examined. The injection date will be considered the start date for each cycle. An episode of bleeding / spotting is defined as any group of one or more days of bleeding or spotting, either consecutive or separated by two days free of bleeding / spotting. Measure:Final result of the Bleeding Journal Timepoints:12 months ; Outcome name:Rates of adverse events that arise (AE) will be provided by the bodys system and by term, for all adverse events, serious adverse events, adverse events related to Medicine. Measure:Final result of the Bleeding Journal Timepoints:12 months ; Outcome name:Changes from baseline to seated blood pressure will be analyzed using a paired t-test. The changes from the baseline! in the values of the weight will be analyzed using the Wilcoxon signed rank test. Measure:Weight and Blood Pressure in Sitting Position Timepoints:12 months | — |
Outcome results
None listed