A6791042
The Pfizer Clinical Research Unit Brussels is conducting a study with a medical device containing 104 mg MPA (medroxyprogesterone acetate) in 0.65 mL suspension for injection and indicated for long-term female contraception via SC injection into the anterior thigh or abdomen every 13 weeks.
You are being invited to take part in a clinical study to evaluate an investigational medicinal product. An investigational medicinal product is a medicinal product that is still being studied to evaluate its efficacy, safety or mode of action.
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This study is seeking healthy female participants.
Women of non-childbearing potential:
You may participate in this study provided that:
- You are 18 or older, and
- You have been surgically sterilised (hysterectomy or bilateral tubal ligation).
Women of childbearing potential:
At each visit to the PCRU, we will check that you are using the appropriate contraception.
You must fulfil one of the following conditions:
- You have a non-hormonal IUD
- You use a diaphragm
- You use condoms
- Your partner has undergone a vasectomy at least six months ago
- You are abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
These non-hormonal contraceptive methods will have to be started at least 14 days before the start of the study and will have to be continued until Day 150 of the study.
In addition to the criteria listed, participants must meet the following requirements:
- Weight of 45 kg minimum
- Body Mass Index of 17.5 - 50 kg/m2
- Non-smoker, ex-smoker, smoker
- Able to meet all study visit requirements There are other requirements for participation in this study. The study staff will explain these to you during the screening process.
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
実施項目
The study is planned to last for approximately 7 months.
Several examinations or procedures will be required in connection with the study:
• A screening examination, during which you will sign the study ICD;
• 1 treatment visit on Day 1 and 21 ambulatory visits on Day 2, 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 127 and 141.
• The follow up visit will take place on Day 150.
a follow-up visit at the end of the study
Some studies require the study team to stay in contact with the participant for a period of time after he or she completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.
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