Contraception for up to 6 months Pregnancy and Childbirth
Conditions
Interventions
Current intervention as of 22/12/2023:
Subjects will be randomly assigned using a 1:1 allocation ratio to receive both of their subcutaneous injections of 6-month DMPA SC in either the abdomen or uppe
Sponsors
Family Health International 360
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Trough MPA levels, MPA accumulation, and the impact of injection site on these PK parameters. Serum MPA concentrations will be measured in the safety subset of 100 subjects on days 0 and 7 and months 1, 3, 4, 5, 6, 9, 10, 11, and 12 2. The safety of 6-month DMPA SC injected every 6 months for 12 months in the abdomen or thigh. The safety measures are: 2.1. Occurrence of adverse events (AEs) throughout the study 2.2. Use of concomitant medications throughout the study 2.3. Vital signs (blood pressure and pulse) and body weight at day 0 and months 3, 6, 9 and 12 2.4. Bleeding and spotting recorded in daily diaries throughout the study 2.5. Hemoglobin and hematocrit at screening and month 12 visits 2.6. Estradiol (E2) at day 0, months 6 and 12 2.7. Safety laboratory tests at screening and month 12 visits (in the Safety Subset of 100 subjects) 2.8. Progesterone (P) and E2 levels at day 0, months 3, 6, 9 and 12 (in the Safety Subset of 100 subjects) 2.9. Bone mineral density (BMD) prior to enrollment and at the end of study participation (in all subjects at the SA investigational center and in the Safety Subset of 100 subjects at the DR investigational center) 3. Satisfaction among users with 6-month DMPA SC injected every 6 months for 12 months in the abdomen or thigh. Satisfaction will be measured using the subject’s responses to the patient satisfaction questionnaire (PSQ) at enrollment, months 6 and 12 and the subject’s responses to questions about the acceptability of the bleeding pattern at months 3, 6, 9 and 12. | — |
Countries
Chile, Dominican Republic, Scotland, South Africa, United Kingdom
Contacts
Public ContactSarah Cordes
Outcome results
None listed