A large, multi-clinic study to evaluate contraceptive efficacy and safety of depot medroxyprogesterone acetate (150 mg/ml) injected under the skin every 6 months
- Conditions
- Contraception for up to 6 monthsPregnancy and Childbirth
- Registration Number
- ISRCTN62695528
- Lead Sponsor
- Family Health International 360
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 750
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
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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
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
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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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence of pregnancy, defined as a positive urine pregnancy test and confirmed by a valid method (i.e., ultrasound and/or serum human chorionic gonadotropin [hCG)] at months 3, 6, 7, 9, and 12
- Secondary Outcome Measures
Name Time Method