Trial Condition(s):
Contraception
Acceptability of long-term progestin-only contraception in Europe
Bayer Identifier:
14688
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.
Inclusion Criteria
- Women aged 20-35 in good general health requesting contraception - Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception - Women who have given a written informed consent to participate in the study (if applicable)
Exclusion Criteria
- The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study - Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovakia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Acceptability of long-term progestin-only contraception in Europe
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Continuation rateTimeframe: At 24 months
Secondary Outcome
- Continuation rateTimeframe: At 12 months
- Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)Timeframe: Initial and after 3, 6, 12 and 24 months
- Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasonsTimeframe: At 24 months
- Incidence of Adverse Events, Serious Adverse EventsTimeframe: During 24 months
- The return to fertility of women discontinuing the method for wish for pregnancyTimeframe: 12 months after discontinuation
Additional Information
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