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.
Condition
Healthy
Age
18 or older
Sex
Female
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.
View more eligibility criteria
1. SPECIFIC EXCLUSIONS FROM THIS STUDY
You may not take part in this study if:
- You are a post-menopausal female.
- You don’t have a regular menstrual cycle (between 21 and 42 days in length).
- You use hormonal contraception (including hormone releasing intrauterine device) within the last 3 months.
- You are taking some medications.
2. COMMON EXCLUSIONS TO MOST OF THE STUDIES
You may not take part in this study if:
- You are outside of the age limits (18 years or older) or weight limits (minimum of 45 kg), or you are outside of the limits of the Body Mass Index (17.5 - 50 kg/m2).
- You are suffering from a chronic illness.
- You are suffering from asthma or from any allergy to a medicine.
- You have taken part in another clinical study involving investigational medicines within the last 30 days.
- You have given blood or constituent elements of blood (platelets) during the two months preceding participation in the study, or you intend to be a donor in the two months following the end of the study (Red Cross standard to guarantee blood cells regeneration). Giving plasma is allowed.
- • You have taken or you are taking drugs.
- • You think you are at risk of being infected with the AIDS virus, hepatitis B or C.
- • You have a history of regular alcohol consumption exceeding 14 drinks/week (1 drink = 90 mL of wine or 240 mL of beer or 30 mL of spirit).
- • You have a known or suspected malignancy of the breast or genital organs.
- • You have a metabolic bone disease.
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.
Long-term follow-up
a follow-up visit at the end of the study
How long is the study?
Approximately 7 months
Compensation
Up to € 2.285, plus travel fees
参加に関心がありますか。
治験登録プロセスをより簡単に、そして円滑に行うため、スクリーン右下のPCRUチャットボットのチャーリーをご使用になることをお勧めします。