check_circleStudy Completed
Contraception
Bayer Identifier:
Trial_Val-03-95
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Fertility after discontinuation of Valette film-coated tablet
Trial purpose
This non-interventional postmarketing surveillance study was
conducted to collect data on fertility after discontinuation of Valette
due to a wish for pregnancy. Fertility data were collected via (i)
evaluation of pregnancy rates within 1 year of discontinuation of
Valette, and (ii) evaluation of the time to pregnancy by the use of
questionnaires presented to gynecologists in private practices.
Response to the questionnaires was provided by the physicians, not
the subjects. Physicians were asked to provide information on age of
study subjects, duration of Valette use, and use of other contraceptive
methods after cessation of Valette.
In case of conception within 1 year after cessation of Valette, the
physician was asked to document the conception cycle. If the woman
did not conceive within 1 year, the physician was asked to document
the reasons for failure to conceive. The completed questionnaire was
to be sent back after diagnosis of pregnancy or after 1 year of
observation following discontinuation of Valette.
The information captured included data up to conception, and data on
pregnancy course and outcome.
conducted to collect data on fertility after discontinuation of Valette
due to a wish for pregnancy. Fertility data were collected via (i)
evaluation of pregnancy rates within 1 year of discontinuation of
Valette, and (ii) evaluation of the time to pregnancy by the use of
questionnaires presented to gynecologists in private practices.
Response to the questionnaires was provided by the physicians, not
the subjects. Physicians were asked to provide information on age of
study subjects, duration of Valette use, and use of other contraceptive
methods after cessation of Valette.
In case of conception within 1 year after cessation of Valette, the
physician was asked to document the conception cycle. If the woman
did not conceive within 1 year, the physician was asked to document
the reasons for failure to conceive. The completed questionnaire was
to be sent back after diagnosis of pregnancy or after 1 year of
observation following discontinuation of Valette.
The information captured included data up to conception, and data on
pregnancy course and outcome.
Key Participants Requirements
Sex
FemaleAge
16 - 41 YearsTrial summary
Enrollment Goal
706Trial Dates
July 1995 - July 2004Phase
Phase 4Could I Receive a placebo
NoProducts
Valette (Dienogest/EE30, BAY86-5038)Accepts Healthy Volunteer
N/APrimary Outcome
- Evaluation of pregnancy ratedate_rangeTime Frame:within 1 year
- Time to pregnancy after discontinuation of Valette
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A