check_circleStudy Completed

Contraception

Bayer Identifier:

18863

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Return to fertility after discontinuation of contraception with Valette because of planned pregnancy

Trial purpose

The main purpose of this observation was to acquire data on the return to fertility after discontinuation of Valette as an aspect of the tolerability and safety of this oral hormonal contraceptive (OC).

Key Participants Requirements

Sex

Female

Age

18 - N/A Years
  • - Women with prescription of Valette (either as first OC or after switch from another OC) who discontinued the use of Valette because of wish to conceive

Trial summary

Enrollment Goal
472
Trial Dates
April 2005 - February 2016
Phase
N/A
Could I Receive a placebo
No
Products
Valette (Dienogest/EE30, BAY86-5038)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many locations, Germany

Primary Outcome

  • Kaplan-Meier estimates to measure the fraction of women becoming pregnant within a certain period of time after discontinuation of contraception with Valette
    date_rangeTime Frame:
    Up to one year
  • Number of pregnancies within 1 year after end of Valette use
    date_rangeTime Frame:
    Up to one year
  • Time to conception after end of Valette use
    date_rangeTime Frame:
    Up to one year

Secondary Outcome

  • Pregnancy course and delivery
    vaginal bleeding during pregnancy, gestational diabetes, drug abuse, nicotine and alcohol consumption, complications during pregnancy and delivery
    date_rangeTime Frame:
    Up to one year
  • Pregnancy outcome and status of newborn(s)
    Basic data of newborn: sex, weight, body length, APGAR and Saling’s score, and comments
    date_rangeTime Frame:
    Up to one year
  • Number of patients with adverse events
    date_rangeTime Frame:
    Up to one year

Trial design

Prospective, multicenter, non-interventional study on the return to fertility after discontinuation of oral contraception with Valette containing 0.03 mg ethinyl estradiol and 2.0 mg dienogest
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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