A Post-Marketing Observational Study of Implanon® Radiopaque among Chinese Women Aged 18 and Older Requesting Contraception (MK-8415-038)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Postmarketing observational study

Study drug and medical condition

• Medical condition to be studied:
  Pregnancy

Population studied

• Short description of the study population:
  Women ≥ 18 years of age at the time of screening requesting contraception at approximately 50 sites throughout China. The identification of eligible subjects was to be based on standard clinical practice and the product labeling. All investigators were to be trained to insert Implanon® Radiopaque. Subjects who were willing to join this survey and sign the ICF were to be enrolled and followed, and the decision of the subject to use the Implanon® Radiopaque would have been made prior to the decision to be involved in the observational study. ; ; Inclusion Criteria; All inclusion criteria were reviewed by the investigator or qualified designee to ensure that the subject qualifies for the study.; • Women ≥18 years of age at the time of screening requesting contraception;; • Capable to answer the questionnaire;; • Decided to use Implanon® Radiopaque for contraception;; • Willing to participate in the survey and give informed consent in writing.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  1900

Study design details

• Main study objective:
  The main objective is to evaluate the overall safety profile of Implanon® Radiopaque.
• Outcomes:
  The participant proportion of (1) drug related AEs, (2) SAEs, (3) discontinuation due to drug-related AE or SAE. (1) To evaluate the topical safety profile of IMPLANON, (2) to assess participant and physician satisfaction with IMPLANON, (3) to estimate the overall contraceptive effectiveness of IMPLANON.
• Data analysis plan:
  Summary statistics of socio-demographic and clinical characteristics of participants on Implanon® Radiopaque treatment will be tabulated. Safety endpoints will be summarized by count, point estimate and corresponding 95% confidence interval (CI).