PER-013-01已完成未知
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.)
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 2001年3月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •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.
排除标准
- •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.
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