None listed
Conditions
Interventions
Medroxiprogesterone Type of group
0.65 mL of AMPD-SC every 3 months in Visits 1, 3, 4 and 5 during 1 year
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Sexually active women wishing long-term contraception (including women who are currently using oral, intrauterine, or barrier methods and wishing to switch to contraception DMPA. • Ages 18 to 49 years (subjects included in the DMO substudy: 18-35 years). • When applicable, they should have stopped using OC for the past 2 months and use a method of barrier contraception (other than IUD) or not be sexually active during this pre-filtering period. • Pregnancy test in negative urine. • Willing to depend on AMPD-SC or AMPD-MI (for subjects in the DM0 substudy) for contraception for at least 1 to 2 years (4 doses: O, 13, 26 and 39 weeks for the main study; the DM0 substudy). • Willing to sign the informed consent. • Must have been menstruating regularly during the past 3 months (cycle length 25-35 days). • Be willing and able to comply with the specific procedures of the study.
Exclusion criteria
Exclusion criteria: • Treatment with AMPD-MI administered within the previous 12 months. • DM0 below the acceptable criteria during filtering: T-rating of the lumbar or femur column 35 years old. • Well documented history of thrombotic events: stroke or venous thromboembolism (deep vein thrombosis or pulmonary embolus). A history of superficial thrombophlebitis is not exclusive. • Undiagnosed abnormal genital bleeding. • Known or suspected pregnancy. • History, within the last 5 years, of alcoholism or abuse of other drugs. • Current uncontrolled hypertension confirmed: defined as> 180 mmHg systolic or> 110 mmHg diastolic. • Hypersensitivity to the study drugs or to the researcher who considers that the progestin is contraindicated. • Concurrent use of other drugs in research. • Previous participation in this study. • History of clinically significant or active liver or kidney disease. • In insulin-dependent diabetes mellitus (DMII) or non-insulin-dependent diabetes mellitus (NIDDM) that is poorly controlled. • Women with tubal ligations, a known diagnosis of infertility, or with partners who are sterile. • Women receiving aminoglutethimide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A positive pregnancy test prior to the next scheduled injection. Urine pregnancy tests will be done at each visit. Measure:Failure in the treatment of the 1-year cumulative pregnancy rate Timepoints:1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The systolic and diastolic blood pressure in the sitting position will be corroborated during the study. The subject should sit down for at least 5 minutes before the blood pressure evaluation in the sitting position. Measure:Blood pressure (Clinical safety) Timepoints:Months 3, 6, 9, 12, 24 ; Outcome name:Sex hormone binding globulin (SHBG), serum estradiol, serum progesterone Measure:Laboratory efficacy Timepoints:On visit 1, at 6 months and 1 year ; Outcome name:Urine pregnancy test (at each visit), AST, ALT, GGT, alkaline phosphatase, total bilirubin, creatinine, glucose, LDL, triglycerides, total cholesterol, routine hematology (including differential), routine urinalysis (except microscopic). Measure:Laboratory Safety Timepoints:On each visit | — |
Countries
Argentina, Brazil, Canada, Chile, Mexico, Peru, United States
Outcome results
None listed