Phase III Contraceptive Study of Subcutaneous Injection of Medroxyprogesterone Acetate for Deposit (AMPD-SC)in women with pregnancy potential in America (including a substudy of Bone Mineral Density [BMD] comparing the effects of AMPD-SC and AMPDIM.)

Not Applicable

• Conditions: -Z308 Other contraceptive management; Other contraceptive management; Z308

• Registration Number: PER-013-01
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-03-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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 <-10; or history of pathological and / or compression fracture.
• Abnormal cervical cytology (PAP required within the last 12 months): CGAII, LIEBG, or LIEAG. However, CEAII (atypical squamous cells of undetermined importance) is allowed.
• The results of mammograms that are suspicious or malignant or require a follow-up of six months. Note: Mammograms (within the last 12 months) are only required for women who are> 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified