ISRCTN62695528进行中（未招募）3 期
A Phase III, open-label, multicenter study to evaluate contraceptive efficacy and safety of depot medroxyprogesterone acetate (150 mg/ml) injected subcutaneously every 6 months
Family Health International 3600 个研究点目标入组 750 人开始时间: 2022年5月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
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
- 性别
- Female
入选标准
- •Current inclusion criteria as of 22/12/2023:
- •Women may be included in the study if they meet all of the following criteria:
- •1. In good general health as determined by medical history, physical and gynecological exams
- •2. Aged 18-35 years at treatment initiation, inclusive
- •3. Willing to provide informed consent, follow all study requirements and rely on 6-month DMPA SC as the only means of contraception for 12 months (i.e., two injections 6 months apart)
- •4. At risk of pregnancy (in a heterosexual relationship, no diagnosis of infertility, no history of tubal ligation or hysterectomy, primary partner is not vasectomized or otherwise sterile, and an average of one or more acts of vaginal intercourse per month)
- •5. Not pregnant and has no desire to become pregnant for at least the next 12 months
- •6. Regular (21-35 days) menstrual cycle (when not using hormonal contraceptives)
- •7. At least two normal menses since the last injection of any injectable contraceptive (if not using other hormonal contraceptives)
- •8. Hemoglobin =9.5 g/dl
- •Previous inclusion criteria:
- •Women may be included in the study if they meet all of the following criteria:
- •1. In good general health as determined by medical history, physical and gynecological exams
- •2. Aged 18-35 years at treatment initiation, inclusive
- •3. Willing to provide informed consent, follow all study requirements and rely on 6-month DMPA SC as the only means of contraception for 12 months (i.e., two injections 6 months apart)
- •4. At risk of pregnancy (in a heterosexual relationship, no diagnosis of infertility, no history of tubal ligation or hysterectomy, primary partner is not vasectomized or otherwise sterile, and an average of one or more acts of vaginal intercourse per month)
- •5. Not pregnant and has no desire to become pregnant for at least the next 12 months
- •6. Regular (21-35 days) menstrual cycle (when not using hormonal contraceptives)
- •7. At least two normal menses since the last injection of any injectable contraceptive (if not using other hormonal contraceptives)
- •8. Hemoglobin =11.0 g/dl
排除标准
- •Current exclusion criteria as of 22/12/2023:
- •Women will be excluded from participating in this study if they meet or have one or more of the following criteria:
- •1. Lactating
- •2. Hypertension with systolic BP =160 mm Hg or diastolic BP =100 mm Hg
- •3. Multiple risk factors for cardiovascular disease (eg, smoking, obesity,diabetes, hypertension and known dyslipidemias)
- •4. Current and/or history of deep venous thrombosis (DVT)/pulmonary embolism (PE)
- •5. Current and/or history of arterial thrombotic or thromboembolic events (ATE) (ie, myocardial infarction, ischaemic heart disease, stroke, or peripheral arterial disease)
- •6. Systemic lupus erythematosus
- •7. Migraine with aura
- •8. Unexplained vaginal bleeding
- •9. Undiagnosed mass in the breast
- •10. Current and/or history of breast cancer
- •11. Diabetes:
- •111. Of >20 years’ duration
- •11.2. Complicated by nephropathy/retinopathy/neuropathy or other vascular disease
- •12. Cirrhosis
- •13. Current or history of liver tumors, benign or malignant, or active liver disease
- •14. Active renal disease
- •15. Known cervical cancer
- •16. History of suicide attempt
- •17. At high risk of sexually transmitted infections (STIs), including any of the following:
- •17.1. Use condoms consistently for STI prevention
- •17.2. Known to be HIV-positive (self or partner)
- •17.3. Use IV drugs (self or partner)
- •17.4. Diagnosis and/or treatment for an STI in the past month (self or partner), excluding recurrent herpes or condyloma
- •17.5. Not in a mutually monogamous relationship having lasted at least 3 months (SA investigational center only)
- •17.6. Tested positive for HIV, gonorrhea, chlamydia, trichomoniasis at screening (SA investigational center only)
- •18. Received an injection of DMPA in the past 9 months
- •19. Received an injection of a combined injectable contraceptive or norethisterone enanthate in the past 4 months
- •20. Currently uses or plans (in the next 12 months) to use a protocol-prohibited drug, another experimental drug, or any other drug that in the opinion of the center PI could complicate interpretation of study findings
- •21. Plans to relocate outside of study area in the next 12 months
- •22. Participates in another clinical study which in the opinion of the center PI would make study participation unsafe, would interfere with adherence to study requirements, or complicate data interpretation
- •23. Has already participated in this study
- •24. History of chronic alcoholism, drug dependence or abuse, psychotic states or severe neurosis or any other condition that, by the judgment of the center PI, might impair the subject’s ability to cooperate
- •25. Current, confirmed diagnosis of COVID-19 unless they have recovered from the disease and have completed their quarantine period per local guidelines
- •26. Any condition (social or medical) which in the opinion of the center PI would make study participation unsafe, would interfere with adherence to study requirements, or complicate data interpretation
- •Previous exclusion criteria:
- •Women will be excluded from participating in this study if they meet or have one or more of the following criteria:
- •1. Lactating
- •2. Hypertension with systolic BP =160 mm Hg or diastolic BP =100 mm Hg
- •3. Multiple risk factors for cardiovascular disease (eg, smoking, obesity, hypertension, known low high-density lipoprotein (HDL), high low-density lipoprotein (LDL), or high triglyceride levels)
- •4. Current and/or history of deep venous thrombosis (DVT)/pulmonary embolism (PE)
- •5. Current and/or history of arterial
研究者
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