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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.

誰が参加できますか

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.

Download the informed consent form

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

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.

 

See if you may qualify

View study calendar

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。

この治験についての詳しい情報:

0800.99.256 (フリーダイヤル:ベルギーから)、00800.26.36.26.36(フリーダイヤル:イギリス、フランス、ドイツ、オランダから)、+32.25.66.78.46(有料ダイヤル:上記以外の国から)に電話し、担当者に詳細をお問い合わせください。または、以下の登録フォームに入力してご送信ください。

「個人情報」とは名前、生年月日、電話番号、健康状態や病状など、一個人としてのあなたに関する情報を意味します。登録フォームに登録される際に当社と共有される個人情報は、医療アンケートや関連資料を送信するためにPCRUブリュッセルによって収集されます。

あなたの個人情報は、厳密に機密扱いで取り扱われ、適応されるすべての法律、特に治験に関するEUとベルギーの法律およびEUとベルギーの個人情報保護に関する法律に準拠して処理されます。

個人情報保護は私たち治験ユニットにとっても非常に重要です、そのため、https://privacycenter.pfizer.com/en/belgiumよりプライバシーに関する通知をお読みください。

 

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