Trial Condition(s):

Contraception

Fertility after discontinuation of Valette film-coated tablet

Bayer Identifier:

Trial_Val-03-95

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

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.

Inclusion Criteria
:
 -  Women with desire for pregnancy after stopping contraception with
Valette
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
706
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Valette (Dienogest/EE30, BAY86-5038)
Accepts Healthy Volunteers
N/A

Where to Participate

Locations
Status
LocationsStatus

Trial Design